510(k) · Cleared
ClearedDiamentor Patient X-Ray Exposure Indicator 07302
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victoreen, Inc. · KPR System, X-Ray, Stationary
Cleared on Oct 2, 1985 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Oct 2, 1985
- Review
- 23 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK853753 Diamentor Patient X-Ray Exposure Indicator 07302Victoreen, Inc. · 1985
- Descendant · cites it directly · 10 of its ownK982319 CaregraphSiemens Medical Solutions USA, Inc. · 1998
- Descendant · 2 generations on · 9 of its ownK123097 Dose Tracking System Model Xidf-DTS801Toshiba America Medical Systems, In.C · 2013
- Descendant · 3 generations on · 8 of its ownK132106 Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
- Descendant · 4 generations on · 7 of its ownK141541 Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014
- Descendant · 5 generations on · 6 of its ownK142736 XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K982319CaregraphSiemens Medical Solutions USA, Inc. · 1998 · cites it directly10descendants
- K123097Dose Tracking System Model Xidf-DTS801Toshiba America Medical Systems, In.C · 2013 · 2 generations on9descendants
- K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013 · 3 generations on8descendants
- K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation · 2014 · 4 generations on7descendants
- K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853753 | Diamentor Patient X-Ray Exposure Indicator 07302 | Victoreen, Inc. | 1985 | — |
| +1 | K982319 | Caregraph | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +2 | K123097 | Dose Tracking System Model Xidf-DTS801 | Toshiba America Medical Systems, In.C | 2013 | — |
| +3 | K132106 | Infinix Angio Workstation W/DTS Software | Toshiba America Medical Systems, In.C | 2013 | — |
| +4 | K141541 | Xidf-AWS801, Angio Workstation, V5.31 | Toshibamedical Systems Corporation | 2014 | — |
| +5 | K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982319 | Caregraph | 1998 | 10 |
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?
- Of its descendants, K982319 (Siemens Medical Solutions USA, Inc., 1998) has gone furthest, with 10 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K853753 · printed Nov 5, 2026
Cite this page
510(k) Report. “K853753: Diamentor Patient X-Ray Exposure Indicator 07302.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K853753
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026