FDA product code FTA: Light, Surgical, Accessories
FTA is the FDA product code for light, surgical, accessories. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 26 510(k) submissions under FTA, from 22 different applicants. The average 510(k) review took 67 days (median 46). FDA has posted 5 recalls for FTA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Accessories |
| 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) exempt |
Compare with all 510(k) review times · Search every FTA clearance
Top FTA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 3 | 2005-08-11 |
| Image Stream Medical, Inc. | 2 | 2010-11-23 |
| Transmedical Corp. | 2 | 1989-03-14 |
| Key Surgical, Inc. | 1 | 2015-09-22 |
| Litex Manufacturing, Inc. | 1 | 2014-09-29 |
17 more applicants have FTA clearances. See the full list in Caduvo.
Most recent FTA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150532 | Key Surgical, Inc. | Universal Light Handle Cover, Light Handle Cover | 2015-09-22 | 204 |
| K142386 | Litex Manufacturing, Inc. | Operating Room Light Handle Adapter | 2014-09-29 | 33 |
| K133554 | Microtek Medical, Inc. an Ecolab Company | SURGICAL LIGHT HANDLE COVER | 2014-04-08 | 140 |
| K133413 | Black Diamond Video | IDSS SLC | 2014-01-07 | 61 |
| K112133 | Oasys Healthcare | OASYS SURGICAL LIGHT CONTROLLER | 2012-03-01 | 219 |
Recalls for FTA devices
5 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-03-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code FTA?
FTA is the FDA product code for light, surgical, accessories. 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 FTA?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTA?
Across 26 cleared submissions the average was 67 days from receipt to decision (median 46).
Which companies have the most FTA clearances?
KARL STORZ Endoscopy-America, Inc. (3); Image Stream Medical, Inc. (2); Transmedical Corp. (2); Key Surgical, Inc. (1); Litex Manufacturing, Inc. (1).
Have FTA devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2023-03-17.
Next steps
- Run an FDA pathway report with predicate devices for product code FTA
- Run a recall and safety report across every FTA manufacturer
- Watch product code FTA 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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