FQZ
14 FDA 510(k) clearances · Product code
62 daysmedian time to decision
247 days90th percentile
14clearances measured
FDA profile
- Official device name
- Thermometer, Clinical Color Change
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2900
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CRY-ACTRACKERCAM (K110305) | Brymill Cryogenic Cystems | 2012-01-13 |
| STERI-AID KIT (K963049) | Steri-Aid, Inc. | 1996-11-12 |
| DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (K946046) | Deroyal Critical Care, Div. Deroyal Technologies | 1995-07-19 |
| POINT CHECKER COLOR STRIP THERMOMETER (K894893) | Kyowa Medex Co., Ltd. | 1990-04-05 |
| FRANKLIN COLLECTOR(R) (K884612) | Franklin Diagnostics, Inc. | 1989-03-27 |
| TEMPA-DOT CLINICAL THERMOMETER SHEATH (K881286) | Pymah Corp. | 1988-06-08 |
| HEALTHCHECK THERM-STRIP (K863181) | Healthcheck Corp. | 1986-09-11 |
| PEE WEE THERMOMETERS (K853515) | Joel R.L. Ehren Kranz | 1985-10-16 |
| BABY TEMP PACIFIER (K822423) | Trp Energy Sensors, Inc. | 1982-10-13 |
| MODIFIED TEMPA-DOT THERMOMETER (K791574) | Info-Chem | 1979-09-12 |
| TEMPO2-I DISPOSABLE THERMOMETERS (K790890) | Airlife, Inc. | 1979-06-27 |
| THERMOMETER RECAL ADAPTER (K772233) | Info-Chem | 1977-12-20 |
| THERMOMETER, SINGLE USE, STRIP, TEMPADOT (K771038) | Organon, Inc. | 1977-06-27 |
| THERMOMETER, SINGLE USE, STRIP, TEMPADOT (K771037) | Info-Chem | 1977-06-27 |
Track FQZ automatically
Every clearance here is in the API, with alerts when new ones post.