← Product Code [FLL](/productcode/FLL) · K964851 # ENTRACARE THERMOMTER MODEL 1000 (K964851) _Entracare Corp. · FLL · Feb 3, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K964851 ## Device Facts - **Applicant:** Entracare Corp. - **Product Code:** [FLL](/productcode/FLL.md) - **Decision Date:** Feb 3, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use The EntraCare Thermometer, Model 1000, is intended to be used under a physician's orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physician. The heart rate timer is also provided to aid in establishing a patient's approximate heart rate. ## Device Story Hand-held, battery-powered electronic thermometer; measures human body temperature (92.0°–108.0°F / 33.0°–42.0°C) via oral or rectal probe. Includes integrated stopwatch-style timer for manual heart rate calculation. Used by clinicians or patients under physician orders in various settings. Output displayed on screen; assists in patient monitoring and vital sign assessment. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Hand-held, battery-powered electronic thermometer. Features include monitor mode, °F/°C display, night-view display, diagnostic self-test, and disposable probe covers. No specific material standards or software architecture details provided. ## Regulatory Identification A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover. ## Special Controls (1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device. ## Predicate Devices - Ivac Corp., Temp-Plus Vital Signs Measurement System, Model 2080 ([K860436](/device/K860436.md)) - Diatek, Thermometer System, Model 600 ([K833568](/device/K833568.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} EntraCare Corp. 510(k) SUMMARY K964851 Page 1 of 3 FEB - 3 1997 # 510(k) SUMMARY OF SAFETY AND EFFICACY DATE PREPARED: November 22, 1996 SUBMITTER: EntraCare, Inc. 14400 College Blvd. Suite 101 Lenexa, KS 66215 Tel: 913-327-7700 Fax: 913-327-7705 CONTACT PERSON: Al Boedeker, Director of Regulatory Affairs TRADE (PROPRIETARY) NAME: EntraCare 1000 Thermometer COMMON NAME: Thermometer CLASSIFICATION NAME: Thermometer, Electronic, Clinical DEVICE CLASSIFICATION: Class II PREDICATE DEVICES: 1. Ivac Corp., Temp-Plus Vital Signs Measurement System, Model 2080 (K860436). 2. Diatek, Thermometer System, Model 600 (K833568). {1} EntraCare Corp. 510(k) SUMMARY Page 2 of 3 ## DESCRIPTION OF DEVICE: The EntraCare Thermometer, Model 1000, is a hand-held, battery powered thermometer. This thermometer is capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). This device also is capable of calculating a persons approximate heart rate through the use of a stopwatch type function and will display the rate simultaneously with temperature. This feature acts like a stop watch and does not attempt to directly measure a patient's pulse. ## STATEMENT OF INTENDED USE: The EntraCare Thermometer, Model 1000, is intended to be used under a physician's orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physician. The heart rate timer is also provided to aid in establishing a patient's approximate heart rate. ## TECHNOLOGICAL CHARACTERISTICS: The new device has the same technological characteristics (i.e., design, material, energy source) as the predicate devices. The specifications are illustrated in the substantial Equivalence Matrix on the following page. {2} EntraCare Corp. 510(k) SUMMARY Page 3 of 3 # SUBSTANTIAL EQUIVALENCE MATRIX | | Candidate EntraCare Model 1000 | Predicate Ivac Corp. Model 2080 | Predicate Diacek Model 600 | | --- | --- | --- | --- | | FEATURES | | | | | MONITOR MODE | YES | YES | YES | | PREDICTIVE MODE | NO | YES | YES | | NIGHT-VIEW DISPLAY | YES | YES | YES | | °F / °C | YES | YES | YES | | PULSE TIMER | YES | YES | YES | | DISPOSABLE PROBE COVER | YES | YES | YES | | BATTERY POWERED | YES | YES | YES | | HAND HELD - PORTABLE | YES | YES | YES | | REPLACEMENT PROBES | YES | YES | YES | | DIAGNOSTIC SELF-TEST | YES | YES | YES | --- **Source:** [https://fda-staging.innolitics.com/device/K964851](https://fda-staging.innolitics.com/device/K964851) **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. 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