FDA product code KQM: Camera, Surgical And Accessories
KQM is the FDA product code for camera, surgical and accessories. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 18 510(k) submissions under KQM, from 13 different applicants. The average 510(k) review took 44 days (median 28). FDA has posted 14 recalls for KQM devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Surgical And Accessories |
| Device class | Class I |
| Regulation | 21 CFR 878.4160 |
| 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 KQM clearance
Top KQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medline Industries, Inc. | 3 | 1986-03-28 |
| Sony Medical Electronics Co. | 2 | 1988-12-22 |
| M.P. Video, Inc. | 2 | 1988-07-26 |
| Technology For Imaging, Inc. | 2 | 1987-11-02 |
| Jedmed Instrument Co. | 1 | 1990-01-24 |
8 more applicants have KQM clearances. See the full list in Caduvo.
Most recent KQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900160 | Jedmed Instrument Co. | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | 1990-01-24 | 12 |
| K890826 | Sony Corp. of America | SONY VIDEO GRAPHIC PRINTER UP-850 | 1989-03-14 | 25 |
| K885042 | Sony Medical Electronics Co. | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | 1988-12-22 | 17 |
| K882958 | Sony Medical Electronics Co. | SONY VIDEO PRINTERS, UP SERIES | 1988-08-04 | 21 |
| K882924 | M.P. Video, Inc. | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | 1988-07-26 | 13 |
Recalls for KQM devices
14 product recalls in 10 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-05-23.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KQM?
KQM is the FDA product code for camera, surgical and accessories. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel.
What device class is KQM?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQM?
Across 18 cleared submissions the average was 44 days from receipt to decision (median 28).
Which companies have the most KQM clearances?
Medline Industries, Inc. (3); Sony Medical Electronics Co. (2); M.P. Video, Inc. (2); Technology For Imaging, Inc. (2); Jedmed Instrument Co. (1).
Have KQM devices been recalled?
Yes: 14 product recalls across 10 recall events; the most recent began 2025-05-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KQM
- Run a recall and safety report across every KQM manufacturer
- Watch product code KQM 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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