Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 25, 2026 Sterilance Medical (Suzhou), Inc. Susan Sun #168 Putuoshan Rd. New District Suzhou, Jiangsu 215153 China Re: K262631 Trade/Device Name: Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: July 29, 2026 Received: July 29, 2026 Dear Susan Sun: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262631 - Susan Sun Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K262631 - Susan Sun Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2026.08.25 11:33:26 -04'00' Colin K. Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262631 | ? | | Please provide the device trade name(s). | | ? | | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | | | | Please provide your Indications for Use below. | | ? | | Disposable Blood Lancet is used for capillary blood sampling. | | | | Please select the types of uses. | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262631 # 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: July 29, 2026 ## 1. Submitter Name: SteriLance Medical (Suzhou) Inc. Address: No.168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu, P. R. China Contact person: Susan Sun Title: Regulatory Affairs Manager E-mail: registration@sterilance.com Tel: 86-0512-65799308 ## 2. Subject Device Information | Trade/Device Name | Disposable Blood Lancet | | --- | --- | | Model | Soft Pro, Softsure, Softsure Pro, Softsense | | Common Name | Blood Lancet | | Regulatory Class | Class II | | Classification Name | Single Use Only Blood Lancet without an Integral Sharps Injury Prevention Feature | | Product Code | QRK | | Regulation Number | 21CFR 878.4850 | ## 3. Predicate Device SteriLance Medical (Suzhou) Inc., Softsure, Softsure Pro, Softsense, Soft Pro Disposable Blood Lancets, under K244031. ## 4. Device Description Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood sampling. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Gamma Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile. ## 5. Intended use & Indication for use Disposable Blood Lancet is used for capillary blood sampling. ## 6. Comparison to the Predicate Device 510(k) Summary 1/3 {5} | Features | Subject device:Disposable blood lancet | Predicate device:Disposable blood lancet (K244031) | Comments | | --- | --- | --- | --- | | Product Code | QRK | QRK | No change | | Manufacturer | SteriLance Medical (Suzhou) Inc | SteriLance Medical (Suzhou) Inc | No change | | Regulation Number | 21 CFR § 878.4850 | 21 CFR § 878.4850 | No change | | Classification class | Class II | Class II | No change | | Type of use | OTC | OTC | No change | | Indications for Use | Disposable Blood Lancet is used for capillary blood sampling | Disposable Blood Lancet is used for capillary blood sampling | No change | | Reuse durability | Single use | Single use | No change | | Sterilization method and SAL | Sterilized by Gamma Radiation SAL=10^{-6} | Sterilized by Gamma Radiation SAL=10^{-6} | No change | | Shelf life | 5 Years | 5 Years | No change | | Gauge | 21G, 23G, 25G, 26G, 28G, 30G, 31G, 32G, 33G | 21G, 23G, 26G, 28G, 30G, 32G, 33G | **Difference^{1}** | | Component | Needle Needle body Protective cap | Needle Needle body Protective cap | No change | | Exposed Needle Length | Soft Pro, Softsure, Softsure Pro: 3.20 ± 0.60mm | Soft Pro, Softsure, Softsure Pro: 3.20 ± 0.60mm | No change | | | Softsense: 2.50 ± 0.60mm | Softsense: 2.50 ± 0.60mm | | | Penetration Depth | Depend on the puncture depth of compatible lancing device | Depend on the puncture depth of compatible lancing device | No change | | Materials of parts in contact with human body | Needle: 304 stainless steel Needle body and cap: PE | Needle: 304 stainless steel Needle body and cap: PE | No change | | Biocompatibility | Complied with ISO10993 series standards | Complied with ISO10993 series standards | No change | | Labeling | Complied with 21 CFR Part 801 and 21 CFR 878.4850 | Complied with 21 CFR Part 801 and 21 CFR 878.4850 | **Difference^{2}** | **Difference$^{1}$**: The physical dimension difference does not raise any safety and effectiveness questions. The needle diameter was verified in the performance test report. **Difference$^{2}$**: The product IFU have been updated to better comply with the requirements of 21 CFR 878.4850. ### 7. Summary of Non-clinical Testing All non-clinical testing conducted on the subject device was designed to demonstrate that the Disposable Blood Lancet is substantially equivalent to the predicate device (Disposable Blood Lancet, K244031) 510(k) Summary 2/3 {6} with respect to critical performance characteristics. Test setup and execution were conducted in accordance with applicable standards. The following performance data were generated to support the substantial equivalence determination. ### 7.1 Performance Testing Bench testing was conducted on the subject device to demonstrate that its critical performance characteristics are substantially equivalent to those of the predicate device. All test results have met the applicable acceptable criteria. - Product appearance and configuration - Needle cap position - Basic dimensions - Steel needle diameter - Exposed needle length - Bonding firmness test - Needle tip sharpness - Double needle, inverted needle, and empty needle - Cleanliness - Biological safety - Barcode / UDI code - Inner carton printing ### 7.1 Biocompatibility Testing The biocompatibility of the subject device was evaluated in accordance with FDA's guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". All tests passed, and the results are considered applicable to the subject device: - Cytotoxicity - Skin sensitization - Intracutaneous reactivity - Acute systemic toxicity - Material-mediated pyrogenicity ### 8. Conclusions Based on the totality of the evidence in this submission, including the comparison of Indications for Use, the comparison of technological characteristics, and the performance testing results, the subject device is substantially equivalent to the predicate device. The non-clinical testing demonstrates that the subject device performs as safely and effectively as the predicate device with all evaluated performance characteristics and biocompatibility endpoints. The addition of 25G and 31G stainless steel needle gauges does not introduce new questions of safety or effectiveness relative to the predicate device. 510(k) Summary 3/3