510(k) · Cleared
ClearedLO-50 Led Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiberoptics Technology, Inc. · NTN Led Light Source
Cleared on Aug 17, 2010 as substantially equivalent to K093792 (Sunoptic Technologies, LLC, 2010) after a 15-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 17, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- NTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961971 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK961971 Q-5000Stryker Endoscopy · 1996
- 2 generations backK082813 Stryker Led LightsourceStryker Corp. · 2008 · Recalled
- 1 generation backK093792 Led Light SourceSunoptic Technologies, LLC · 2010
- This deviceK102167 LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121724 Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
- Descendant · cites it directly · 1 of its ownK103813 SOPRO 281Sopro · 2011
- Descendant · 2 generations on · 0 of its ownK131226 Novaprobe Led Light SourceNovaprobe Incorporated · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −2 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| −1 | K093792 | Led Light Source | Sunoptic Technologies, LLC | 2010 | — |
| 0 (this device) | K102167 | LO-50 Led Light Source | Fiberoptics Technology, Inc. | 2010 | — |
| +1 | K121724 | Endolight Led 1.1 Endolightled 1.2 | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +1 | K103813 | SOPRO 281 | Sopro | 2011 | — |
| +2 | K131226 | Novaprobe Led Light Source | Novaprobe Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 NTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K093792 | Led Light SourceSummary page 1…ight Source is substantially equivalent in terms of safety and effectiveness to the currently marketed predicate device: Sunoptics Technologies LLS-050 LED Uight Source (K093792). Performance and Safety Comparison to Predicate Device: Both light sources were non-clinically tested to determine the safety an… | 2010 |
What descends from it? (3)
2 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 14 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K121724 (Richard Wolf Medical Instruments Corp., 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K093792.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NTN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NTN
Too few NTN 510(k)s in any year since 2007 to give a median.
Recalls per year · NTN
No recall names NTN since 2007.
Adverse event reports per year · NTN
42in 2025
MAUDE reports naming product code NTN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 47 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102167: LO-50 Led Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102167
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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