FDA product code FHF: System, Evacuator, Fluid
FHF is the FDA product code for system, evacuator, fluid. It is a Class II device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FHF, from 3 different applicants. The average 510(k) review took 96 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | System, Evacuator, Fluid |
| Device class | Class II |
| Regulation | 21 CFR 876.4370 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FHF clearance
Top FHF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Modern Medical Equipment Mfg., Ltd. | 1 | 2010-05-19 |
| Applied Medical | 1 | 2001-02-01 |
| The Minnesota Back Brace Co. | 1 | 1977-10-28 |
Most recent FHF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093479 | Modern Medical Equipment Mfg., Ltd. | DISPOSABLE SUCTION AND IRRIGATION SYSTEM | 2010-05-19 | 191 |
| K003443 | Applied Medical | SUCTION IRRIGATOR | 2001-02-01 | 87 |
| K771986 | The Minnesota Back Brace Co. | CATHETER, MEDIASTINAL&PERICARDIAL | 1977-10-28 | 9 |
Recalls for FHF devices
openFDA lists no recalls for product code FHF.
Frequently asked questions
What is FDA product code FHF?
FHF is the FDA product code for system, evacuator, fluid. It is a Class II device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel.
What device class is FHF?
Class II, regulation 21 CFR 876.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FHF?
Across 3 cleared submissions the average was 96 days from receipt to decision (median 87).
Which companies have the most FHF clearances?
Modern Medical Equipment Mfg., Ltd. (1); Applied Medical (1); The Minnesota Back Brace Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHF
- Run a recall and safety report across every FHF manufacturer
- Watch product code FHF 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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