Thermometer, Clinical Color Change
FDA product code FQZ · Class I (low risk) · 21 CFR 880.2900 · General Hospital
14510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110305 | Cry-ActrackercamFQZ · Special | Brymill Cryogenic Cystems | 01/13/2012SE |
| K963049 | Steri-Aid KitFQZ · Traditional | Steri-Aid, Inc. | 11/12/1996SE |
| K946046 | Deroyal Technologices, Inc. Liquid Crystal Skin Temperature StripFQZ · Traditional | Deroyal Critical Care, Div. Deroyal Technologies | 07/19/1995SE |
| K894893 | Point Checker Color Strip ThermometerFQZ · Traditional | Kyowa Medex Co., Ltd. | 04/05/1990SE |
| K884612 | Franklin Collector(R)FQZ · Traditional | Franklin Diagnostics, Inc. | 03/27/1989SE |
| K881286 | Tempa-Dot Clinical Thermometer SheathFQZ · Traditional | Pymah Corp. | 06/08/1988SE |
| K863181 | Healthcheck Therm-StripFQZ · Traditional | Healthcheck Corp. | 09/11/1986SE |
| K853515 | Pee Wee ThermometersFQZ · Traditional | Joel R.L. Ehren Kranz | 10/16/1985SE |
| K822423 | Baby Temp PacifierFQZ · Traditional | Trp Energy Sensors, Inc. | 10/13/1982SE |
| K791574 | Modified Tempa-Dot ThermometerFQZ · Traditional | Info-Chem | 09/12/1979SE |
| K790890 | TEMPO2-I Disposable ThermometersFQZ · Traditional | Airlife, Inc. | 06/27/1979SE |
| K772233 | Thermometer Recal AdapterFQZ · Traditional | Info-Chem | 12/20/1977SE |
| K771038 | Thermometer, Single Use, Strip, TempadotFQZ · Traditional | Organon, Inc. | 06/27/1977SE |
| K771037 | Thermometer, Single Use, Strip, TempadotFQZ · Traditional | Info-Chem | 06/27/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1633-2023 Class I | Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring…There have been reports of skin burns to children wearing the device. | BearCare, Inc. | 05/10/2023Terminated |
| Z-2162-2013 Class II | Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical…TempaDot products may have been mislabeled. | Medical Indicators, Inc. | 07/10/2013Terminated |