FDA product code FZF: Splint, Extremity, Inflatable, External
FZF is the FDA product code for splint, extremity, inflatable, external. It is a Class I device, regulated under 21 CFR 878.3900 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under FZF, from 4 different applicants. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Extremity, Inflatable, External |
| Device class | Class I |
| Regulation | 21 CFR 878.3900 |
| 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 FZF clearance
Top FZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vinyl Technology, Inc. | 4 | 1987-11-23 |
| R. Evans Corp. | 1 | 1988-04-29 |
| Hospitak, Inc. | 1 | 1985-09-19 |
| Svenol Andersen | 1 | 1983-09-12 |
Most recent FZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881516 | R. Evans Corp. | COMPRESAID | 1988-04-29 | 18 |
| K874051 | Vinyl Technology, Inc. | INFLATABLE FULL LEG SPLINT | 1987-11-23 | 49 |
| K874053 | Vinyl Technology, Inc. | INFLATABLE FULL ARM SPLINT | 1987-11-23 | 49 |
| K874050 | Vinyl Technology, Inc. | INFLATABLE FOOT & ANKLE SPLINT | 1987-11-23 | 49 |
| K874052 | Vinyl Technology, Inc. | INFLATABLE HALF LEG SPLINT | 1987-11-23 | 49 |
Recalls for FZF devices
openFDA lists no recalls for product code FZF.
Frequently asked questions
What is FDA product code FZF?
FZF is the FDA product code for splint, extremity, inflatable, external. It is a Class I device, regulated under 21 CFR 878.3900 and reviewed by the General and Plastic Surgery panel.
What device class is FZF?
Class I, regulation 21 CFR 878.3900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZF?
Across 7 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most FZF clearances?
Vinyl Technology, Inc. (4); R. Evans Corp. (1); Hospitak, Inc. (1); Svenol Andersen (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FZF
- Run a recall and safety report across every FZF manufacturer
- Watch product code FZF 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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