FDA product code KPW: Device, Beam Limiting, X-Ray, Diagnostic
KPW is the FDA product code for device, beam limiting, x-ray, diagnostic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel. FDA has cleared 16 510(k) submissions under KPW, from 14 different applicants. The average 510(k) review took 59 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Device, Beam Limiting, X-Ray, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 892.1610 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KPW clearance
Top KPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ralco S.R.L. | 2 | 2003-08-01 |
| Tecnomed, Inc. | 2 | 1982-03-05 |
| Lumos, Inc. | 1 | 2010-01-12 |
| Umi International | 1 | 2006-12-28 |
| Toshiba Medical Systems | 1 | 1995-10-18 |
9 more applicants have KPW clearances. See the full list in Caduvo.
Most recent KPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093596 | Lumos, Inc. | LUMOS, MODEL R 72B | 2010-01-12 | 53 |
| K062788 | Umi International | COLLIMATOR, MODEL M-38 | 2006-12-28 | 101 |
| K030487 | Ralco S.R.L. | R 72 | 2003-08-01 | 168 |
| K954310 | Toshiba Medical Systems | BLA-800A | 1995-10-18 | 33 |
| K946320 | Ralco S.R.L. | R 302 | 1995-05-11 | 134 |
Recalls for KPW devices
openFDA lists no recalls for product code KPW.
Frequently asked questions
What is FDA product code KPW?
KPW is the FDA product code for device, beam limiting, x-ray, diagnostic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel.
What device class is KPW?
Class II, regulation 21 CFR 892.1610. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPW?
Across 16 cleared submissions the average was 59 days from receipt to decision (median 37).
Which companies have the most KPW clearances?
Ralco S.R.L. (2); Tecnomed, Inc. (2); Lumos, Inc. (1); Umi International (1); Toshiba Medical Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPW
- Run a recall and safety report across every KPW manufacturer
- Watch product code KPW 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times