FDA product code FEM: Accessories, Photographic, For Endoscope (Exclude Light Sources)
FEM is the FDA product code for accessories, photographic, for endoscope (exclude light sources). It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FEM, from 3 different applicants. The average 510(k) review took 108 days (median 60). FDA has posted 5 recalls for FEM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FEM clearance
Top FEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polaroid Corp. | 2 | 1981-10-19 |
| Hydro-Med Products, Inc. | 1 | 1994-10-28 |
| Reznik Instruments | 1 | 1981-10-19 |
Most recent FEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940152 | Hydro-Med Products, Inc. | CAMERA COVER WITH TEAR TIP | 1994-10-28 | 298 |
| K812542 | Polaroid Corp. | POLAROID INSTANT ENDOCAMERA | 1981-10-19 | 45 |
| K812201 | Reznik Instruments | PHOTOGRAPHIC EQUIPMENT | 1981-10-19 | 76 |
| K792512 | Polaroid Corp. | POLAROID LAND CAMERA FOR ENDOSCOPY | 1979-12-20 | 15 |
Recalls for FEM devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-07-21.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code FEM?
FEM is the FDA product code for accessories, photographic, for endoscope (exclude light sources). It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FEM?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FEM?
Across 4 cleared submissions the average was 108 days from receipt to decision (median 60).
Which companies have the most FEM clearances?
Polaroid Corp. (2); Hydro-Med Products, Inc. (1); Reznik Instruments (1).
Have FEM devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2023-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FEM
- Run a recall and safety report across every FEM manufacturer
- Watch product code FEM 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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