← Product Code [LPZ](/productcode/LPZ) · BK251308 # Biowy Multi-Chamber Freezing Bag (BK251308) _Biowy Corporation Lake Forest, CA 92630 · LPZ · Mar 17, 2026 · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/BK251308 ## Device Facts - **Applicant:** Biowy Corporation Lake Forest, CA 92630 - **Product Code:** [LPZ](/productcode/LPZ.md) - **Decision Date:** Mar 17, 2026 - **Decision:** SESE - **Device Class:** Class U ## Indications for Use The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. ## Device Story Sterile, flexible, multi-chamber plastic container system; used for cryopreservation of hematopoietic progenitor cells. System includes freezing bag, transfer/process bag, supernatant collecting bag, extension tubing, and connectors. Operates by containing cells during liquid nitrogen storage (-196°C) and subsequent thawing (+37°C). Used in clinical or laboratory settings by trained personnel. Provides a closed system for processing and storage; maintains cell viability during freeze-thaw cycles. ## Clinical Evidence Bench testing only. Verification included mechanical strength, biocompatibility, and durability studies during liquid nitrogen freeze/thaw cycles. ## Technological Characteristics Materials: EVA (freezing bag), PVC, ABS, PP (tubing/connectors), PVC (accessory bags). Form factor: Multi-chamber flexible container with integrated tubing and accessory bags. Capacity: 10-35ml. Sterilization: Sterile. Energy source: None (passive storage). ## Predicate Devices - Biowy Multi-Chamber Freezing Bag ([BK251308](/device/BK251308.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} # Special 510(k) ## 510(k) Summary 510(k) Owner: Biowy Corporation 27031 Vista Terrace Lake Forest, California 92630 Telephone No. 1-949-305-8211 Primary Contact: Arthur Lu Biowy Corporation Telephone: 1-949-305-8211 Fax: 1-866-506-5094 Email: alu@biowy.com Date prepared: March 30, 2026 Device name: Trade name: Biowy Multi-Chamber Freezing Bag Set Common Name: Freezing Bag Classification name: Container, Frozen Donor Tissue Storage FDA Product Code: LPZ Classification: Unclassified Predicate Device: Biowy Multi-Chamber Freezing Bag (BK251308) Device Description: The Biowy multi-chamber freezing bag set is a sterile plastic flexible container intended only for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. The freezing bag product is comprised of a multi-chamber freezing bag with twist-off ports, extension tubing and connectors with a transfer/process bag and a supernatant collecting bag. Indications for Use: The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. ### Technical Characteristics The Biowy Multi-Chamber Freezing Bag Set is substantially equivalent to the predicate in indications for use, design, technology/principal of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness. | | **Predicate** | **Subject Device** | | --- | --- | --- | | | **Biowy Multi-Chamber Freezing Bag (BK251308)** | **Biowy Multi-Chamber Freezing Bag Set** | | **Indications for Use** | The Biowy Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. | The Biowy Multi-Chamber Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. | | Specimen | Hematopoietic progenitor cells | Same as the predicate | | Materials | Freezing bag: EVA | Freezing bag: EVA (same as the predicate) | {1} | | Accessory bag: Mixing bag (EVA) Extension tubing/connectors: PVC, ABS, PP | Accessory bags: Transfer/process bag and supernatant collecting bag (PVC, different from the predicate) Extension tubing/connectors: PVC, ABS, PP (same as the predicate) | | --- | --- | --- | | Design | A sterile multi-chamber EVA freezing bag with integrated tubing and a mixing bag. | A sterile multi-chamber EVA freezing bag with integrated tubing, a transfer/process bag and a supernatant collecting bag. | | Freeze capacity | 10-35ml | 10-35ml | **Nonclinical Performance Data:** Verification of device performance was established with acceptable results from the following non-clinical tests: mechanical strength, biocompatibility, durability in freeze/thaw studies in liquid nitrogen. **Conclusions:** The Biowy Multi-Chamber Freezing Bag Set is substantially equivalent to the predicate device. --- **Source:** [https://fda-staging.innolitics.com/device/BK251308](https://fda-staging.innolitics.com/device/BK251308) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com