FDA product code FZI: Apparatus, Air Handling, Enclosure
FZI is the FDA product code for apparatus, air handling, enclosure. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under FZI, from 4 different applicants. The average 510(k) review took 55 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Air Handling, Enclosure |
| 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 FZI clearance
Top FZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 2 | 1978-03-09 |
| Central Georgia Ancillary Health Systems | 1 | 1991-05-06 |
| E.M. Adams | 1 | 1991-03-21 |
| Alcon Laboratories | 1 | 1985-11-15 |
Most recent FZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911132 | Central Georgia Ancillary Health Systems | MULTIPLE, SURGICAL DRAPE PACK | 1991-05-06 | 53 |
| K910468 | E.M. Adams | STERILE DISPOSABLE DRAPE(S) | 1991-03-21 | 45 |
| K854159 | Alcon Laboratories | ELLIPTI-PUNCH | 1985-11-15 | 35 |
| K772394 | Edward Weck, Inc. | KALRN FACE-LIFE SCISSORS | 1978-03-09 | 72 |
| K772395 | Edward Weck, Inc. | DAVIS RHYTIDECTOMY | 1978-03-09 | 72 |
Recalls for FZI devices
openFDA lists no recalls for product code FZI.
Frequently asked questions
What is FDA product code FZI?
FZI is the FDA product code for apparatus, air handling, enclosure. 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 FZI?
Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZI?
Across 5 cleared submissions the average was 55 days from receipt to decision (median 53).
Which companies have the most FZI clearances?
Edward Weck, Inc. (2); Central Georgia Ancillary Health Systems (1); E.M. Adams (1); Alcon Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FZI
- Run a recall and safety report across every FZI manufacturer
- Watch product code FZI 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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