510(k) · Cleared
ClearedEndolight Led 1.1 Endolightled 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FCW Light Source, Fiberoptic, Routine
Cleared on Sep 20, 2012 as substantially equivalent to K983628 (Richard Wolf Medical Instruments Corp., 1998) and 2 other predicates after a 100-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Sep 20, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K961971 (1996). 6 ancestors in all, the oldest K952696 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK961971 Q-5000Stryker Endoscopy · 1996
- 3 generations backK082813 Stryker Led LightsourceStryker Corp. · 2008 · Recalled
- 2 generations backK093792 Led Light SourceSunoptic Technologies, LLC · 2010
- 1 generation backK102167 LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010
- This deviceK121724 Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
- Descendant · cites it directly · 0 of its ownK131226 Novaprobe Led Light SourceNovaprobe Incorporated · 2014
Most influential descendants
Showing 1 of 1 · See all- K131226Novaprobe Led Light SourceNovaprobe Incorporated · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −3 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| −2 | K093792 | Led Light Source | Sunoptic Technologies, LLC | 2010 | — |
| −1 | K102167 | LO-50 Led Light Source | Fiberoptics Technology, Inc. | 2010 | — |
| 0 (this device) | K121724 | Endolight Led 1.1 Endolightled 1.2 | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +1 | K131226 | Novaprobe Led Light Source | Novaprobe Incorporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FCW? 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? (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 |
|---|---|---|---|
| * | K983628 | Xenon Light Source Auto Lip 5123, Model 2123.011Summary page 1…_______________ IK868 I Auto LP 5123 Xenon Light Projector I Richard Wolf Medical Inst. Corp. I K983628 (Product Code GCT) _______________ 2 K082813 2 Stryker LED Light Source… | 1998 |
| * | K082813 | Stryker Led LightsourceSummary page 1…I Richard Wolf Medical Inst. Corp. I K983628 (Product Code GCT) _______________ 2 K082813 2 Stryker LED Light Source (Product Code FCW) 2 Stryker Endoscopy 3 1217 3 LO-50 LED Light Sour… | 2008 |
| * | K102167 | LO-50 Led Light SourceSummary page 3…nt to the existing 5 10(k) cleared devices sold by: Richard Wolf Medical Instruments Corporation (K983628), Stryker Endoscopy (K082813), and Fiberoptics Technology, Inc (K102167). Section / Page-5rl3ofA 4DEPARTMENT '#fl OF HEA… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131226 | Novaprobe Led Light Source | 2014 | 0 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K131226 (Novaprobe Incorporated, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K983628.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ENDOLIGHT LED Light Source Projector is intended to be used to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121724: Endolight Led 1.1 Endolightled 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121724
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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