FDA product code NFM: Expander, Tissue, Orbital
NFM is the FDA product code for expander, tissue, orbital. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under NFM, from 2 different applicants. The average 510(k) review took 172 days (median 172).
Classification
| Field | Value |
|---|---|
| Device name | Expander, Tissue, Orbital |
| Device class | Class II |
| Regulation | 21 CFR 886.3320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NFM clearance
Top NFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovia, LLC | 1 | 2006-08-08 |
| Iop, Inc. | 1 | 2001-08-13 |
Most recent NFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060151 | Innovia, LLC | ORBITAL TISSUE EXPANDER (OTE) | 2006-08-08 | 200 |
| K010852 | Iop, Inc. | OSMED TISSUE EXPANDER | 2001-08-13 | 145 |
Recalls for NFM devices
openFDA lists no recalls for product code NFM.
Frequently asked questions
What is FDA product code NFM?
NFM is the FDA product code for expander, tissue, orbital. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel.
What device class is NFM?
Class II, regulation 21 CFR 886.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFM?
Across 2 cleared submissions the average was 172 days from receipt to decision (median 172).
Which companies have the most NFM clearances?
Innovia, LLC (1); Iop, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NFM
- Run a recall and safety report across every NFM manufacturer
- Watch product code NFM 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times