510(k) · Cleared

Recalled · 2008

Stryker Ureteral Illuminator System Iii

K982542510(k) TraditionalCleared Sep 22, 199863-day reviewClass II21 CFR 876.4020Recalls 1

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

Stryker Endoscopy · FCS Light, Catheter, Fiberoptic, Glass, Ureteral

Cleared on Sep 22, 1998 as substantially equivalent to K945088 (Gabriel Medical, Inc., 1995) after a 63-day review. Its family tree reaches back 1 generation to 1995. 36 later devices descend from it. It has been recalled once.

Decided: Sep 22, 1998
Review: 63 days
Class: Class II
Product code: FCS
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K945088 (1995). 36 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945088 Gabriel Ureteral Illuminator System IIGabriel Medical, Inc. · 1995
This deviceK982542 Stryker Ureteral Illuminator System IiiStryker Endoscopy · 1998
Descendant · cites it directly · 35 of its ownK061548 Stryker Ureteral Illumination System IVStryker Corp. · 2006
Descendant · 2 generations on · 34 of its ownK151243 STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and…Stryker Endoscopy · 2015
Descendant · 3 generations on · 33 of its ownK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
Descendant · 4 generations on · 26 of its ownK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
Descendant · 5 generations on · 25 of its ownK210088 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2006high 6 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 36 · See all

K061548Stryker Ureteral Illumination System IVStryker Corp. · 2006 · cites it directly35descendants
K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy · 2015 · 2 generations on34descendants
K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker · 2018 · 3 generations on33descendants
K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker · 2020 · 4 generations on26descendants
K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker · 2021 · 5 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945088	Gabriel Ureteral Illuminator System II	Gabriel Medical, Inc.	1995	—
0 (this device)	K982542	Stryker Ureteral Illuminator System Iii	Stryker Endoscopy	1998	—
+1	K061548	Stryker Ureteral Illumination System IV	Stryker Corp.	2006	—
+2	K151243	STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS…	Stryker Endoscopy	2015	—
+3	K182160	1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K…	Stryker	2018	1
+4	K202592	Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging…	Stryker	2020	—
+5	K210088	1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…	Stryker	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2015	1	0
2018	1	0
2019	2	0
2020	2	0
2021	3	0
2022	5	0
2023	5	0
2024	4	0
2025	6	0
2026	6	0

FIG. 1 — Lineage of K982542, 1995–2026Source: 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 FCS? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K945088	Gabriel Ureteral Illuminator System II Summary page 1 …he Stryker Ureteral Illuminator System III is equivalent in safety and effectiveness to a variety of devices currently marketed (Gabriel Ureteral Illuminator System II - K945088) which are used in the applications noted above for general transillumination purposes. This device does not raise new issues wh…	Gabriel Medical, Inc.	1995	—

Also cleared against K945088: 1 other device →

What descends from it? (36)

See all 36

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061548	Stryker Ureteral Illumination System IV	Stryker Corp.	2006	35

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2008	Not classified	Z-1866-2008	Other	Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K061548 (Stryker Corp., 2006) has gone furthest, with 35 descendants of its own.
1 other device also cites its predicate K945088.

How does its category compare?

All FCS devices

FCS Light, Catheter, Fiberoptic, Glass, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCS

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCS

Too few FCS 510(k)s in any year since 2007 to give a median.

Recalls per year · FCS

2in 2008

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FCS

3in 2025

2007high 19 (2022) · low 0 (2007)2025

MAUDE reports naming product code FCS, 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	—	2	1
2009	0	—	0	0
2010	0	—	0	2
2011	0	—	0	1
2012	0	—	0	3
2013	0	—	0	1
2014	0	—	0	1
2015	1	—	0	5
2016	0	—	0	3
2017	0	—	0	17
2018	0	—	0	6
2019	0	—	0	4
2020	0	—	0	9
2021	0	—	0	6
2022	0	—	0	19
2023	0	—	0	4
2024	0	—	0	3
2025	0	—	0	3
2026	0	—	0	—

What is it indicated for?

Read the full statement (102 words)

The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the surgeon identify the ureter(s) during open or laparoscopic surgical procedures of the lower abdomen or pelvic areas. As a general surgery transillumination device, the Stryker Ureteral Illuminator System III replaces and is substantially equivalent to existing predicate fiberoptic light ureteral catheter transillumination devices.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982542: Stryker Ureteral Illuminator System Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982542

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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