510(k) · Cleared
ClearedLessray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saferay Spine, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Nov 29, 2013 as substantially equivalent to K123226 (Saferay Spine, LLC, 2012) after a 67-day review. Its family tree reaches back 2 generations to 2002. 14 later devices descend from it.
- Decided
- Nov 29, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013841 (2002). 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013841 3DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002
- 1 generation backK123226 LessraySaferay Spine, LLC · 2012
- This deviceK132970 LessraySaferay Spine, LLC · 2013
- Descendant · cites it directly · 13 of its ownK142243 LessRay with TrackingSaferay Spine, LLC · 2014
- Descendant · 2 generations on · 12 of its ownK170800 NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 4 of its ownK173314 LessRay SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 3 of its ownK180038 NuVasive Pulse SystemNu Vasive, Incorporated · 2018
- Descendant · 3 generations on · 3 of its ownK173736 TrackXTrack X Technology, LLC · 2018 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K142243LessRay with TrackingSaferay Spine, LLC · 2014 · cites it directly13descendants
- K170800NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017 · 2 generations on12descendants
- K173314LessRay SystemNu Vasive, Incorporated · 2017 · 2 generations on4descendants
- K180038NuVasive Pulse SystemNu Vasive, Incorporated · 2018 · 3 generations on3descendants
- K173736TrackXTrack X Technology, LLC · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013841 | 3DFIS, Model Ies-FL-101 | 3Dsharp, Inc. | 2002 | — |
| −1 | K123226 | Lessray | Saferay Spine, LLC | 2012 | — |
| 0 (this device) | K132970 | Lessray | Saferay Spine, LLC | 2013 | — |
| +1 | K142243 | LessRay with Tracking | Saferay Spine, LLC | 2014 | — |
| +2 | K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 | — |
| +2 | K173314 | LessRay System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018 | — |
| +3 | K173736 | TrackX | Track X Technology, LLC | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K123226 | LessraySummary page 1…on Regulation: 21 CFR 892.1650 Panel: Radiology Product Code: OWB3 Predicate Device: K 123226 - Submitter's own previously cleared device Indication for Use: The LessRay" is intended for use in any application where a fluo… | 2012 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142243 | LessRay with Tracking | 2014 | 13 |
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 11 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142243 (Saferay Spine, LLC, 2014) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K123226.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The LessRay® is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132970: Lessray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132970
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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