FDA product code FLK: Thermometer, Clinical Mercury
FLK is the FDA product code for thermometer, clinical mercury. It is a Class II device, regulated under 21 CFR 880.2920 and reviewed by the General Hospital panel. FDA has cleared 33 510(k) submissions under FLK, from 31 different applicants. The average 510(k) review took 89 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Thermometer, Clinical Mercury |
| Device class | Class II |
| Regulation | 21 CFR 880.2920 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FLK clearance
Top FLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abco Dealers, Inc. | 3 | 1981-12-18 |
| Amsia Intl., Inc. | 1 | 1996-03-28 |
| Rg Ent., Inc. | 1 | 1996-03-25 |
| Kentron Health Care, Inc. | 1 | 1995-12-15 |
| Makol Medical Instruments Corp. | 1 | 1995-03-28 |
26 more applicants have FLK clearances. See the full list in Caduvo.
Most recent FLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960185 | Amsia Intl., Inc. | AMSINO CLINICAL THERMOMETER | 1996-03-28 | 72 |
| K960224 | Rg Ent., Inc. | GERATHERM MERCUIRY FREE CLINICAL THERMOMETER | 1996-03-25 | 68 |
| K953465 | Kentron Health Care, Inc. | KENTEMP | 1995-12-15 | 144 |
| K942483 | Makol Medical Instruments Corp. | CLINICAL GLASS THERMOMETER | 1995-03-28 | 307 |
| K941673 | Polymedica Industries, Inc. | MEDIAID UNIVERSAL THERMOMETER | 1994-08-25 | 142 |
Recalls for FLK devices
openFDA lists no recalls for product code FLK.
Frequently asked questions
What is FDA product code FLK?
FLK is the FDA product code for thermometer, clinical mercury. It is a Class II device, regulated under 21 CFR 880.2920 and reviewed by the General Hospital panel.
What device class is FLK?
Class II, regulation 21 CFR 880.2920. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FLK?
Across 33 cleared submissions the average was 89 days from receipt to decision (median 72).
Which companies have the most FLK clearances?
Abco Dealers, Inc. (3); Amsia Intl., Inc. (1); Rg Ent., Inc. (1); Kentron Health Care, Inc. (1); Makol Medical Instruments Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FLK
- Run a recall and safety report across every FLK manufacturer
- Watch product code FLK 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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