FDA product code · Radiology
KPRSystem, X-Ray, Stationary
Product code KPR covers System, X-Ray, Stationary, a Class II device regulated under 21 CFR 892.1680. FDA has cleared 356 devices in this code, 6 of them in the last 12 months. Median review time across the 356 most recent decisions is 57 days. openFDA lists 168 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1680
- Review panel
- Radiology
- Clearances
- 356
What is happening in KPR right now?
KPR (System, X-Ray, Stationary) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1299-2026, Z-0464-2026, Z-0466-2026, Z-0044-2026). Adverse events reported in 2026-03 ran high — 9 reports against an expected 0 to 8 (KPR:MAUDE:2026-03). The code is crowded, scoring 71 of 100 — 155 companies hold a clearance here and 6 arrived in the last 12 months (KPR:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1299-2026, Z-0464-2026, Z-0466-2026, Z-0044-2026 |
| Adverse-event spike | Serious | KPR:MAUDE:2026-03 |
| Crowding | Context | KPR:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KPR?
FDA has cleared 356 devices under product code KPR since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260482 | DRE Duo | Jpi Healthcare Co, Ltd. | |
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | |
| K250738 | YSIO X.pree | Siemens Medical Solutions | |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. |
How long does FDA review take for KPR?
The median FDA review time for KPR is 57 days, measured across the 356 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KPR?
openFDA lists 168 recall records against product code KPR. A recall record covers one firm's corrective action and may span many device lots.
Z-1299-2026Open, ClassifiedFUJIFILM Healthcare Americas Corporation
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Z-0464-2026Open, ClassifiedPhilips Medical Systems DMC GmbH
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-0466-2026Open, ClassifiedPhilips Medical Systems DMC GmbH
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-0044-2026Open, ClassifiedFUJIFILM Healthcare Americas Corporation
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Z-1553-2025Open, ClassifiedPhilips North America LLC
Potential for collimator to fall as a result of incorrect installation.
Showing the 5 most recently initiated of 168. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KPR?
MAUDE holds 120 adverse-event reports naming product code KPR, 32 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KPR unusual?
One month sits above KPR's own expected range: 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | 0–9 | Within expected (0–9) | |
| 3 | 0–7 | Within expected (0–7) | |
| 9 | 0–8 | Above expected (0–8) |
30 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KPR.
What are the predicate devices in KPR?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KPR?
Across the 356 most recent decisions, these applicants filed most often in KPR.
| Applicant | Recent clearances |
|---|---|
| Samsung Electronics Co., Ltd. | 20 |
| Siemens Medical Solutions USA, Inc. | 13 |
| Imaging Dynamics Company , Ltd. | 11 |
| Carestream Health, Inc. | 10 |
| Octostop, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in KPR file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Carestream Health, Inc. | 11 | 2 |
| GE Medical Systems, LLC | 9 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KPR
Get an email the morning anything changes in KPR — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.