FDA product code KQA: Device, Beam Limiting, X-Ray, Therapeutic
KQA is the FDA product code for device, beam limiting, x-ray, therapeutic. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under KQA, from 4 different applicants. The average 510(k) review took 130 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Device, Beam Limiting, X-Ray, Therapeutic |
| Device class | Class II |
| Regulation | 21 CFR 892.5900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KQA clearance
Top KQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oldelft Corp. of America | 1 | 1992-06-05 |
| Perkins Mfg. Co. | 1 | 1989-06-01 |
| Ellis Pharmaceutical Consulting, Inc. | 1 | 1985-02-01 |
| Cmsi | 1 | 1979-02-15 |
Most recent KQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914784 | Oldelft Corp. of America | PAPILLION PROCTOSCOPE | 1992-06-05 | 226 |
| K885126 | Perkins Mfg. Co. | PHILIPS RT250 COLLIMATOR (PK8050) | 1989-06-01 | 171 |
| K844180 | Ellis Pharmaceutical Consulting, Inc. | THE MCP-70-SE SYSTEM | 1985-02-01 | 98 |
| K790168 | Cmsi | COLLIMATOR, BILATERIAL | 1979-02-15 | 23 |
Recalls for KQA devices
openFDA lists no recalls for product code KQA.
Frequently asked questions
What is FDA product code KQA?
KQA is the FDA product code for device, beam limiting, x-ray, therapeutic. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel.
What device class is KQA?
Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQA?
Across 4 cleared submissions the average was 130 days from receipt to decision (median 134).
Which companies have the most KQA clearances?
Oldelft Corp. of America (1); Perkins Mfg. Co. (1); Ellis Pharmaceutical Consulting, Inc. (1); Cmsi (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQA
- Run a recall and safety report across every KQA manufacturer
- Watch product code KQA 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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