FDA product code FQZ: Thermometer, Clinical Color Change
FQZ is the FDA product code for thermometer, clinical color change. It is a Class I device, regulated under 21 CFR 880.2900 and reviewed by the General Hospital panel. FDA has cleared 14 510(k) submissions under FQZ, from 12 different applicants. The average 510(k) review took 100 days (median 58). FDA has posted 2 recalls for FQZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Thermometer, Clinical Color Change |
| Device class | Class I |
| Regulation | 21 CFR 880.2900 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FQZ clearance
Top FQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Info-Chem | 3 | 1979-09-12 |
| Brymill Cryogenic Cystems | 1 | 2012-01-13 |
| Steri-Aid, Inc. | 1 | 1996-11-12 |
| Deroyal Critical Care, Div. Deroyal Technologies | 1 | 1995-07-19 |
| Kyowa Medex Co., Ltd. | 1 | 1990-04-05 |
7 more applicants have FQZ clearances. See the full list in Caduvo.
Most recent FQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110305 | Brymill Cryogenic Cystems | CRY-ACTRACKERCAM | 2012-01-13 | 345 |
| K963049 | Steri-Aid, Inc. | STERI-AID KIT | 1996-11-12 | 110 |
| K946046 | Deroyal Critical Care, Div. Deroyal Technologies | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP | 1995-07-19 | 219 |
| K894893 | Kyowa Medex Co., Ltd. | POINT CHECKER COLOR STRIP THERMOMETER | 1990-04-05 | 247 |
| K884612 | Franklin Diagnostics, Inc. | FRANKLIN COLLECTOR(R) | 1989-03-27 | 143 |
Recalls for FQZ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2023-05-10.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code FQZ?
FQZ is the FDA product code for thermometer, clinical color change. It is a Class I device, regulated under 21 CFR 880.2900 and reviewed by the General Hospital panel.
What device class is FQZ?
Class I, regulation 21 CFR 880.2900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FQZ?
Across 14 cleared submissions the average was 100 days from receipt to decision (median 58).
Which companies have the most FQZ clearances?
Info-Chem (3); Brymill Cryogenic Cystems (1); Steri-Aid, Inc. (1); Deroyal Critical Care, Div. Deroyal Technologies (1); Kyowa Medex Co., Ltd. (1).
Have FQZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-05-10.
Next steps
- Run an FDA pathway report with predicate devices for product code FQZ
- Run a recall and safety report across every FQZ manufacturer
- Watch product code FQZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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