510(k) · Cleared
ClearedDefinium Tempo Select
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hualun Medical Systems Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Aug 28, 2025 as substantially equivalent to K191699 (Ge Hualun Medical Systems Co., Ltd., 2019) after a 167-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Aug 28, 2025
- Review
- 167 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K862120 (1986). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations between
- 3 generations backK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- 2 generations backK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- 1 generation backK191699 Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019 · Recalled
- This deviceK250788 Definium Tempo SelectGe Hualun Medical Systems Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 8 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 7 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 6 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK042602 Revolution XR/D Digital Radiographic Imaging System with Manual…Ge Medical Systems, LLC · 2005
- 4 generations backK050704 Modification to: Revolution XR/D Digital Radiographic Imaging System…General Electric Co. · 2005 · Recalled
- 3 generations backK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- 2 generations backK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- 1 generation backK191699 Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019 · Recalled
- This deviceK250788 Definium Tempo SelectGe Hualun Medical Systems Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −8 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −7 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −6 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −5 | K042602 | Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting | Ge Medical Systems, LLC | 2005 | — |
| −4 | K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with… | General Electric Co. | 2005 | 2 |
| −3 | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| −2 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
| −1 | K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co., Ltd. | 2019 | 3 |
| 0 (this device) | K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191699 | Discovery XR656 HD with VolumeRadSummary page 6…fication: Class II Product Code: KPR Subsequent Product MQB Code(s): Predicate Device: Discovery XR656 HD with VolumeRad (K191699) 21 CFR 807.92(a)(3) 21CFR 892.1680 (KPR, MQB) Class II Predicate Device GE Hualun… | 2019 |
| † | K231892 | Definium Pace Select | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 13 ancestors have a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The Definium Tempo Select is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. The device is not intended for mammographic applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250788: Definium Tempo Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250788
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026