510(k) · Cleared

Recalled · Class II · 2023

Stryker Led Lightsource

K082813510(k) TraditionalCleared Dec 19, 200886-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Corp. · FCW Light Source, Fiberoptic, Routine

Cleared on Dec 19, 2008 as substantially equivalent to K961971 (Stryker Endoscopy, 1996) after an 86-day review. Its family tree reaches back 1 generation to 1996. 27 later devices descend from it. It has been recalled once.

Decided: Dec 19, 2008
Review: 86 days
Class: Class II
Product code: FCW
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K961971 (1996). 27 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK961971 Q-5000Stryker Endoscopy · 1996
This deviceK082813 Stryker Led LightsourceStryker Corp. · 2008
Descendant · cites it directly · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
Descendant · 2 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
Descendant · cites it directly · 7 of its ownK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
Descendant · 2 generations on · 6 of its ownK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
Descendant · cites it directly · 6 of its ownK093792 Led Light SourceSunoptic Technologies, LLC · 2010

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2010high 3 (2010) · low 0 (2017)2026

Most influential descendants

Showing 5 of 27 · See all

K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · cites it directly9descendants
K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 2 generations on7descendants
K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC · 2010 · cites it directly7descendants
K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew · 2016 · 2 generations on6descendants
K093792Led Light SourceSunoptic Technologies, LLC · 2010 · cites it directly6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961971	Q-5000	Stryker Endoscopy	1996	—
0 (this device)	K082813	Stryker Led Lightsource	Stryker Corp.	2008	—
+1	K142922	SpyGlass DS Direct Visualization System	Boston Scientific Corporation	2015	1
+2	K181439	SpyGlass DS and DS II Direct Visualization System	Boston Scientific Corporation	2018	—
+1	K101734	Visionscope High Definition Endoscopy Camera System with; Camera Control Unit…	Visionscope Technologies, LLC	2010	—
+2	K153606	LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head…	Smith & Nephew	2016	—
+1	K093792	Led Light Source	Sunoptic Technologies, LLC	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2011	1	0
2012	2	0
2013	1	0
2014	1	0
2015	3	0
2016	1	0
2018	1	0
2019	3	0
2020	2	0
2021	1	0
2022	2	0
2023	1	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K082813, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K961971	Q-5000 Summary page 1 …ource is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the Stryker Quantum 5000 Light Source (K961971). Substantial Equivalence: The technological differences between the LED Light Source (L9000) and the Stryke…	Stryker Endoscopy	1996	—

Also cleared against K961971: 1 other device →

What descends from it? (27)

See all 27

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142922	SpyGlass DS Direct Visualization System	Boston Scientific Corporation	2015	9
K101734	Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…	Visionscope Technologies, LLC	2010	7
K093792	Led Light Source	Sunoptic Technologies, LLC	2010	6
K130819	CLL- V1 Light Source	Olympus Winter & Ibe GmbH	2013	1
K121724	Endolight Led 1.1 Endolightled 1.2	Richard Wolf Medical Instruments Corp.	2012	1
K131226	Novaprobe Led Light Source	Novaprobe Incorporated	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 2, 2023	Class II	Z-1474-2023	Employee error	Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K142922 (Boston Scientific Corporation, 2015) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K961971.

How does its category compare?

All FCW devices

FCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · FCW

1in 2014

2007high 2 (2008) · low 0 (2007)2026

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

2007high 4 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FCW

140in 2025

2007high 713 (2010) · low 2 (2008)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 Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

The light source is an integral component of a visualization system which consists of a video camera, video monitor, video recorder, video printer, light cable and scope.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082813 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082813: Stryker Led Lightsource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082813

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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