FDA product code KPX: Changer, Radiographic Film/Cassette
KPX is the FDA product code for changer, radiographic film/cassette. It is a Class II device, regulated under 21 CFR 892.1860 and reviewed by the Radiology panel. FDA has cleared 26 510(k) submissions under KPX, from 17 different applicants. The average 510(k) review took 72 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Changer, Radiographic Film/Cassette |
| Device class | Class II |
| Regulation | 21 CFR 892.1860 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KPX clearance
Top KPX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canon USA, Inc. | 5 | 1995-02-01 |
| Mallinckrodt Group, Inc. | 4 | 1991-05-20 |
| B C Medical , Ltd. | 2 | 1993-10-08 |
| Elema-Schonander, Inc. | 2 | 1990-09-04 |
| Regulatory Consultants TO the Medical Device Indus | 1 | 1994-08-09 |
12 more applicants have KPX clearances. See the full list in Caduvo.
Most recent KPX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945635 | Canon USA, Inc. | TRANS X-1000 | 1995-02-01 | 77 |
| K935157 | Regulatory Consultants TO the Medical Device Indus | ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES | 1994-08-09 | 285 |
| K934850 | Victoreen, Inc. | NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS | 1993-11-22 | 41 |
| K933035 | B C Medical , Ltd. | BCM-600TX | 1993-10-08 | 108 |
| K925598 | Acoma Medical Imaging, Inc. | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | 1993-02-01 | 88 |
Recalls for KPX devices
openFDA lists no recalls for product code KPX.
Frequently asked questions
What is FDA product code KPX?
KPX is the FDA product code for changer, radiographic film/cassette. It is a Class II device, regulated under 21 CFR 892.1860 and reviewed by the Radiology panel.
What device class is KPX?
Class II, regulation 21 CFR 892.1860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPX?
Across 26 cleared submissions the average was 72 days from receipt to decision (median 40).
Which companies have the most KPX clearances?
Canon USA, Inc. (5); Mallinckrodt Group, Inc. (4); B C Medical , Ltd. (2); Elema-Schonander, Inc. (2); Regulatory Consultants TO the Medical Device Indus (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPX
- Run a recall and safety report across every KPX manufacturer
- Watch product code KPX 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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