Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2900](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2900) → FQZ — Thermometer, Clinical Color Change

# FQZ · Thermometer, Clinical Color Change

_General Hospital · 21 CFR 880.2900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ

## Overview

- **Product Code:** FQZ
- **Device Name:** Thermometer, Clinical Color Change
- **Regulation:** [21 CFR 880.2900](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2900)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K110305](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K110305.md) | CRY-ACTRACKERCAM | Brymill Cryogenic Cystems | Jan 13, 2012 | SESE |
| [K963049](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K963049.md) | STERI-AID KIT | Steri-Aid, Inc. | Nov 12, 1996 | SESE |
| [K946046](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K946046.md) | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP | Deroyal Critical Care, Div. Deroyal Technologies | Jul 19, 1995 | SESE |
| [K894893](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K894893.md) | POINT CHECKER COLOR STRIP THERMOMETER | Kyowa Medex Co., Ltd. | Apr 5, 1990 | SESE |
| [K884612](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K884612.md) | FRANKLIN COLLECTOR(R) | Franklin Diagnostics, Inc. | Mar 27, 1989 | SESE |
| [K881286](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K881286.md) | TEMPA-DOT CLINICAL THERMOMETER SHEATH | Pymah Corp. | Jun 8, 1988 | SESE |
| [K863181](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K863181.md) | HEALTHCHECK THERM-STRIP | Healthcheck Corp. | Sep 11, 1986 | SESE |
| [K853515](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K853515.md) | PEE WEE THERMOMETERS | Joel R.L. Ehren Kranz | Oct 16, 1985 | SESE |
| [K822423](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K822423.md) | BABY TEMP PACIFIER | Trp Energy Sensors, Inc. | Oct 13, 1982 | SESE |
| [K791574](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K791574.md) | MODIFIED TEMPA-DOT THERMOMETER | Info-Chem | Sep 12, 1979 | SESE |
| [K790890](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K790890.md) | TEMPO2-I DISPOSABLE THERMOMETERS | Airlife, Inc. | Jun 27, 1979 | SESE |
| [K772233](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K772233.md) | THERMOMETER RECAL ADAPTER | Info-Chem | Dec 20, 1977 | SESE |
| [K771038](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K771038.md) | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Organon, Inc. | Jun 27, 1977 | SESE |
| [K771037](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K771037.md) | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Info-Chem | Jun 27, 1977 | SESE |

## Top Applicants

- Info-Chem — 3 clearances
- Airlife, Inc. — 1 clearance
- Brymill Cryogenic Cystems — 1 clearance
- Deroyal Critical Care, Div. Deroyal Technologies — 1 clearance
- Franklin Diagnostics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ)

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