510(k) · Cleared
ClearedX-Ray Assist Bar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ralph Lindel, D.C. · KPR System, X-Ray, Stationary
Cleared on Jul 8, 1997 as substantially equivalent to K933778 (Whitmore Ent., Inc., 1993) after a 39-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 8, 1997
- Review
- 39 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933778 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK933778 Whitmore Ankle X-Ray Extension (Axe)Whitmore Ent., Inc. · 1993
- This deviceK972000 X-Ray Assist BarRalph Lindel, D.C. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933778 | Whitmore Ankle X-Ray Extension (Axe) | Whitmore Ent., Inc. | 1993 | — |
| 0 (this device) | K972000 | X-Ray Assist Bar | Ralph Lindel, D.C. | 1997 | — |
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? (3)
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 |
|---|---|---|---|
| * | K933778 | Whitmore Ankle X-Ray Extension (Axe)Summary page 1…st Bar Predicate Device Information: Chest X-Support Steady Rest™, Distributed by Cone Instruments Whitmore Enterprises, Inc., Whitmore Ankle X-Ray Extension (AXE) K#933778 Device Description: Lower bar adjusts and locks to the horizontal position for the patient to hold onto and adjusts down to the… | 1993 |
| * | — | Chest X-Support Named without a submission number | |
| * | — | Steady Rest™ Named without a submission number | |
| † | K944040 | Planet Thermoplastic Immobilization System | 1995 |
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
This device is intended to accurately position the patient's body in a steady, precise position during X-Ray procedures (erect lateral thoracic, lateral lumbar, lateral chest and lateral abdomen plain film X-Rays).
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/K972000 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972000: X-Ray Assist Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972000
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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