← Product Code [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL) · K964605 # BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000) (K964605) _Thermoscan, Inc. · FLL · May 16, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K964605 ## Device Facts - **Applicant:** Thermoscan, Inc. - **Product Code:** [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL.md) - **Decision Date:** May 16, 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 Braun ThermoScan pro-2000 Instant Thermometer is intended for the intermittent measurement and monitoring of human body temperature by medical professionals. It is intended for use on people of all ages. ## Device Story Handheld infrared thermometer; measures thermal radiation from tympanic membrane and auditory canal. Operated by medical professionals in clinical settings. Device captures infrared signal; processes data to calculate temperature; applies mathematical adjustment to measured ear canal temperature to approximate oral range. Output displayed on device screen in °F or °C. Provides rapid 1-second measurement; aids clinical decision-making regarding patient fever status and temperature monitoring. ## Clinical Evidence Clinical comparison and repeatability study conducted across four age groups (0-3, 4-10, 11-65, >65 years). Results demonstrated equivalent performance to predicate IR-2000. Clinical repeatability met ASTM E1112-86 standards for all age groups. ## Technological Characteristics Infrared tympanic thermometer. Measures natural thermal radiation. Accuracy compliant with ASTM E1112-86. Resolution 0.1°F/C. Operating range 60.8-104°F. Measurement time 1 second. Handheld form factor, 195g. No software algorithm class specified. ## 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 - THERMOSCAN Instant Thermometer, Model IR-2000 - THERMOSCAN Instant Thermometer, Model IR-5000 - THERMOSCAN Instant Thermometer, Model IR-6000 ## 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} K 964605 # 510(k) SUMMARY Submitter's Name: Thermoscan, Inc. MAY 16 1997 Address: 10421 Pacific Center Court San Diego, CA 92121 Phone: (619) 550-2100 Contact: Frances E. Harrison Date of Summary: 11/15/96 Name of Device: Braun ThermoScan® pro-2000 Instant Thermometer Predicate Device: THERMOSCAN Instant Thermometer, Model IR-2000 THERMOSCAN Instant Thermometer, Model IR-5000 THERMOSCAN Instant Thermometer, Model IR-6000 Device Description: The Braun ThermoScan pro-2000 Instant Thermometer, is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces Intended Use: The Braun ThermoScan pro-2000 Instant Thermometer is intended for the intermittent measurement and monitoring of human body temperature by medical professionals. It is intended for use on people of all ages. Technological Characteristics: The Braun ThermoScan Instant Thermometers, Model PRO-2000, IR-2000, IR-5000 and IR-6000 have the same general design and incorporate similar technologies, materials and components. The primary function of the Braun ThermoScan pro-2000 Instant Thermometer is the same as the ThermoScan Instant Thermometer, Models IR-2000, IR-5000 and IR-6000 for the measurement of body temperature and raise no new questions of safety and effectiveness. ThermoScan Inc. concludes that the Braun ThermoScan pro-2000 Instant Thermometer, is substantially equivalent to the ThermoScan IR-2000, IR-5000 and IR-6000. {1} Page 2 510(k) Summary Braun ThermoScan pro-2000 Instant Thermometer ## PRODUCT SPECIFICATIONS: | Model Number | PRO-2000 | | --- | --- | | Temperature Ranges | | | Patient temperature range | 80.0 to 108.0°F (26.6 to 42.2°C) | | Ambient temperature operating range | 60.8 to 104°F (16.0 to 40.0°C) | | Temperature scales (user selectable) | °F or °C | | Storage temperature range | -4.0 to 122.0°F (-20.0 to 50.0°C) | | Display modes | EAR (The displayed EAR temperature is the actual measured ear canal temperature plus a mathematical adjustment to approximate the familiar oral range. However, this is not necessarily the same as an oral temperature measured at the same time.) | | Humidity Range | 15 - 95% Noncondensing | | Resolution | 0.1°F or C | | Shock | Withstands one meter drop in thermometer storage cover | **Accuracy:** Meets American Society for Testing and Materials (ASTM) Standard E1112-86 as it pertains to IR thermometers | Applicable patient ages | All ages | | | --- | --- | --- | | Patient temperature range | Error °F | Error °C | | <96.4°F (<35.8°C) | ±0.5 | ±0.3 | | 96.4 to <98.0°F (35.8 to <37.0°C) | ±0.3 | ±0.2 | | 98.0 to 102.0°F (37.0 to 39.0°C) | ±0.2 | ±0.1 | | >102.0 to 106.0°F (>39.0 to 41.0°C) | ±0.3 | ±0.2 | | >106.0°F (>41.0°C) | ±0.5 | ±0.3 | ## Time | Measurement time | 1 second | | --- | --- | | Minimum time between readings | 8 seconds | | Automatic “power down” | 60 seconds | ## Weight 7 oz (195 gm) {2} Page 3 510(k) Summary Braun ThermoScan pro-2000 Instant Thermometer ## SUMMARY OF TESTING: ### Clinical Results A comparison study and clinical repeatability testing was performed on the following four age groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs. The comparison study demonstrated that the Braun ThermoScan pro-2000 Instant Thermometer measured ear temperature equivalently to the IR-2000 in all age groups. The clinical repeatability for each age group met ASTM standards. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K964605](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K964605) **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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