510(k) · Cleared
ClearedLessRay with Tracking
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 18, 2014 as substantially equivalent to K132970 (Saferay Spine, LLC, 2013) and 1 other predicate after a 97-day review. Its family tree reaches back 3 generations to 2002. 13 later devices descend from it.
- Decided
- Nov 18, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K013841 (2002). 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK013841 3DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002
- 2 generations backK123226 LessraySaferay Spine, LLC · 2012
- 1 generation backK132970 LessraySaferay Spine, LLC · 2013
- This deviceK142243 LessRay with TrackingSaferay Spine, LLC · 2014
- Descendant · cites it directly · 12 of its ownK170800 NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 4 of its ownK173314 LessRay SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 3 of its ownK180038 NuVasive Pulse SystemNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 3 of its ownK173736 TrackXTrack X Technology, LLC · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K170800NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017 · cites it directly12descendants
- K173314LessRay SystemNu Vasive, Incorporated · 2017 · cites it directly4descendants
- K180038NuVasive Pulse SystemNu Vasive, Incorporated · 2018 · 2 generations on3descendants
- K173736TrackXTrack X Technology, LLC · 2018 · 2 generations on3descendants
- K210574NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013841 | 3DFIS, Model Ies-FL-101 | 3Dsharp, Inc. | 2002 | — |
| −2 | K123226 | Lessray | Saferay Spine, LLC | 2012 | — |
| −1 | K132970 | Lessray | Saferay Spine, LLC | 2013 | — |
| 0 (this device) | K142243 | LessRay with Tracking | Saferay Spine, LLC | 2014 | — |
| +1 | K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 | — |
| +1 | K173314 | LessRay System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018 | — |
| +2 | K173736 | TrackX | Track X Technology, LLC | 2018 | 2 |
| +3 | K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K132970 | LessraySummary page 4…JAA – system, x-ray, fluoroscopic, image-intensified Date Prepared: October 17, 2014 Predicate Device: K132970, LessRay® Indication for Use: LessRay® with Tracking is intended for use in any application where a fluoroscope is incorporated t… | 2013 |
| * | K123226 | LessraySummary page 5…similar technological characteristics, and results of performance testing, LessRay® with Tracking is substantially equivalent to the previously cleared LessRay® device (K123226). Table 1: Device Comparison Table Proposed Device Predicate Device 510… | 2012 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K170800 (Nu Vasive, Incorporated, 2017) has gone furthest, with 12 descendants of its own.
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. 2014, 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?
LessRay® with Tracking 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/K142243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142243: LessRay with Tracking.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142243
Report an extraction error
Are you the manufacturer?
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