FDA product code FTF: Illuminator, Non-Remote
FTF is the FDA product code for illuminator, non-remote. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under FTF, from 2 different applicants. The average 510(k) review took 88 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Illuminator, Non-Remote |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FTF clearance
Top FTF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Suncoast Medical Manufacturers, Inc. | 3 | 1984-04-24 |
| Medical Vision Industries, Inc. | 1 | 2004-09-13 |
Most recent FTF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041621 | Medical Vision Industries, Inc. | LITEPORT LP100 SURGICAL ILLUMINATOR | 2004-09-13 | 89 |
| K840373 | Suncoast Medical Manufacturers, Inc. | FLEXIBLE ILLUMINATOR 10 | 1984-04-24 | 88 |
| K840372 | Suncoast Medical Manufacturers, Inc. | FLEXIBLE ILLUMINATOR 15 | 1984-04-24 | 88 |
| K840371 | Suncoast Medical Manufacturers, Inc. | FLEXIBLE ILLUMINATOR 5 | 1984-04-24 | 88 |
Recalls for FTF devices
openFDA lists no recalls for product code FTF.
Frequently asked questions
What is FDA product code FTF?
FTF is the FDA product code for illuminator, non-remote. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FTF?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k).
How long does a 510(k) take for product code FTF?
Across 4 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most FTF clearances?
Suncoast Medical Manufacturers, Inc. (3); Medical Vision Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FTF
- Run a recall and safety report across every FTF manufacturer
- Watch product code FTF 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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