FDA product code KPR: System, X-Ray, Stationary
KPR is the FDA product code for system, x-ray, stationary. It is a Class II device, regulated under 21 CFR 892.1680 and reviewed by the Radiology panel. FDA has cleared 359 510(k) submissions under KPR, 42 in the last five years, from 163 different applicants. The average 510(k) review took 94 days (median 58); 168 days on average over the last three years. FDA has posted 168 recalls for KPR devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Stationary |
| Device class | Class II |
| Regulation | 21 CFR 892.1680 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KPR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 118 |
| 2018 | 15 | 54 |
| 2019 | 12 | 74 |
| 2020 | 16 | 57 |
| 2021 | 6 | 61 |
| 2022 | 8 | 61 |
| 2023 | 9 | 91 |
| 2024 | 11 | 144 |
| 2025 | 8 | 156 |
| 2026 | 6 | 205 |
Compare with all 510(k) review times · Search every KPR clearance
Top KPR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Samsung Electronics Co., Ltd. | 21 | 2026-08-27 |
| Siemens Medical Solutions USA, Inc. | 14 | 2026-08-31 |
| Imaging Dynamics Company , Ltd. | 11 | 2007-06-22 |
| Carestream Health, Inc. | 10 | 2024-03-12 |
| Philips Medical Systems (Cleveland), Inc. | 8 | 1998-12-11 |
158 more applicants have KPR clearances. See the full list in Caduvo.
Most recent KPR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260227 | DRTECH Corporation | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | 2026-09-08 | 225 |
| K260488 | Siemens Medical Solutions USA, Inc. | MULTIX Impact; MULTIX Impact C | 2026-08-31 | 199 |
| K260481 | Samsung Electronics Co., Ltd. | GC85A | 2026-08-27 | 195 |
| K260482 | Jpi Healthcare Co, Ltd. | DRE Duo | 2026-06-15 | 122 |
| K253446 | Dk Medical Systems Co., Ltd. | AeroDR TX c02 | 2026-04-10 | 190 |
Recalls for KPR devices
168 product recalls in 129 recall events; 25 initiated in the last five years and 34 still open. Most recent: 2026-01-09.
| Year | Recalls |
|---|---|
| 2017 | 8 |
| 2018 | 14 |
| 2019 | 6 |
| 2020 | 8 |
| 2021 | 8 |
| 2022 | 3 |
| 2023 | 8 |
| 2024 | 4 |
| 2025 | 9 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KPR?
KPR is the FDA product code for system, x-ray, stationary. It is a Class II device, regulated under 21 CFR 892.1680 and reviewed by the Radiology panel.
What device class is KPR?
Class II, regulation 21 CFR 892.1680. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPR?
Across 359 cleared submissions the average was 94 days from receipt to decision (median 58).
Which companies have the most KPR clearances?
Samsung Electronics Co., Ltd. (21); Siemens Medical Solutions USA, Inc. (14); Imaging Dynamics Company , Ltd. (11); Carestream Health, Inc. (10); Philips Medical Systems (Cleveland), Inc. (8).
Have KPR devices been recalled?
Yes: 168 product recalls across 129 recall events; the most recent began 2026-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KPR
- Run a recall and safety report across every KPR manufacturer
- Watch product code KPR 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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