FDA product code FZH: Apparatus, Air Handling, Room
FZH is the FDA product code for apparatus, air handling, room. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under FZH, from 4 different applicants. The average 510(k) review took 87 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Air Handling, Room |
| Device class | Class II |
| Regulation | 21 CFR 878.5070 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FZH clearance
Top FZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardio-Med-Associates, Inc. | 1 | 1993-03-20 |
| Spec Systems, Inc. | 1 | 1988-01-27 |
| Custom Industries, Inc. | 1 | 1987-06-01 |
| Dupaco, Inc. | 1 | 1977-02-23 |
Most recent FZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923233 | Cardio-Med-Associates, Inc. | CARDIO-PAK LAPAROTOMY PACK | 1993-03-20 | 262 |
| K875305 | Spec Systems, Inc. | MODEL UCA / SPEC SYSTEM UCA | 1988-01-27 | 29 |
| K871901 | Custom Industries, Inc. | ULTRAFLOW | 1987-06-01 | 17 |
| K770084 | Dupaco, Inc. | OPERATING ROOM VENTILATOR | 1977-02-23 | 40 |
Recalls for FZH devices
openFDA lists no recalls for product code FZH.
Frequently asked questions
What is FDA product code FZH?
FZH is the FDA product code for apparatus, air handling, room. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General and Plastic Surgery panel.
What device class is FZH?
Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZH?
Across 4 cleared submissions the average was 87 days from receipt to decision (median 34).
Which companies have the most FZH clearances?
Cardio-Med-Associates, Inc. (1); Spec Systems, Inc. (1); Custom Industries, Inc. (1); Dupaco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FZH
- Run a recall and safety report across every FZH manufacturer
- Watch product code FZH 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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