FDA product code CAM: Yoke Assembly, Medical Gas
CAM is the FDA product code for yoke assembly, medical gas. It is a Class I device, regulated under 21 CFR 868.6885 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under CAM, from 5 different applicants. The average 510(k) review took 79 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Yoke Assembly, Medical Gas |
| Device class | Class I |
| Regulation | 21 CFR 868.6885 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CAM clearance
Top CAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Penox Technologies, Inc. | 4 | 1985-06-18 |
| American Gage & Medical, Inc. | 1 | 1994-03-11 |
| Siemens Elema AB | 1 | 1984-06-07 |
| Spica, Inc. | 1 | 1978-03-30 |
| Bel-Med, Inc. | 1 | 1977-03-15 |
Most recent CAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935283 | American Gage & Medical, Inc. | YOKE ASSEMBLY MEDICAL GAS | 1994-03-11 | 128 |
| K851219 | Penox Technologies, Inc. | FILL HOSE SAFETY ADAPTER | 1985-06-18 | 84 |
| K851215 | Penox Technologies, Inc. | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER | 1985-06-18 | 84 |
| K851217 | Penox Technologies, Inc. | PENOX DUAL FLOW MINIFOLD | 1985-06-18 | 84 |
| K851216 | Penox Technologies, Inc. | PENOX DUAL FEED MANIFOLD | 1985-06-18 | 84 |
Recalls for CAM devices
openFDA lists no recalls for product code CAM.
Frequently asked questions
What is FDA product code CAM?
CAM is the FDA product code for yoke assembly, medical gas. It is a Class I device, regulated under 21 CFR 868.6885 and reviewed by the Anesthesiology panel.
What device class is CAM?
Class I, regulation 21 CFR 868.6885. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAM?
Across 8 cleared submissions the average was 79 days from receipt to decision (median 84).
Which companies have the most CAM clearances?
Penox Technologies, Inc. (4); American Gage & Medical, Inc. (1); Siemens Elema AB (1); Spica, Inc. (1); Bel-Med, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CAM
- Run a recall and safety report across every CAM manufacturer
- Watch product code CAM 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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