510(k) · Cleared
ClearedStryker Ureteral Illumination System IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Cleared on Sep 28, 2006 as substantially equivalent to K982542 (Stryker Endoscopy, 1998) after a 115-day review. Its family tree reaches back 2 generations to 1995. 35 later devices descend from it.
- Decided
- Sep 28, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- FCS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945088 (1995). 35 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945088 Gabriel Ureteral Illuminator System IIGabriel Medical, Inc. · 1995
- 1 generation backK982542 Stryker Ureteral Illuminator System IiiStryker Endoscopy · 1998 · Recalled
- This deviceK061548 Stryker Ureteral Illumination System IVStryker Corp. · 2006
- Descendant · cites it directly · 34 of its ownK151243 STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and…Stryker Endoscopy · 2015
- Descendant · 2 generations on · 33 of its ownK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- Descendant · 3 generations on · 26 of its ownK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
- Descendant · 4 generations on · 25 of its ownK210088 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- Descendant · 5 generations on · 19 of its ownK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy · 2015 · cites it directly34descendants
- K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker · 2018 · 2 generations on33descendants
- K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker · 2020 · 3 generations on26descendants
- K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker · 2021 · 4 generations on25descendants
- K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker · 2021 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945088 | Gabriel Ureteral Illuminator System II | Gabriel Medical, Inc. | 1995 | — |
| −1 | K982542 | Stryker Ureteral Illuminator System Iii | Stryker Endoscopy | 1998 | 1 |
| 0 (this device) | K061548 | Stryker Ureteral Illumination System IV | Stryker Corp. | 2006 | — |
| +1 | K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS… | Stryker Endoscopy | 2015 | — |
| +2 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| +3 | K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging… | Stryker | 2020 | — |
| +4 | K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM… | Stryker | 2021 | — |
| +5 | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable… | Stryker | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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
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 |
|---|---|---|---|
| * | K982542 | Stryker Ureteral Illuminator System IiiSummary page 1…Illumination System IV is substantially equivalent in terms of safety and effectiveness to the currently marketed Stryker Ureteral Illuminator System III (ref: K982542). The Stryker Universal U-Kit will conform to the following voluntary safety and performance standards: ISO 10993, Blue… | 1998 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | 2015 | 34 |
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 11 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K151243 (Stryker Endoscopy, 2015) has gone furthest, with 34 descendants of its own.
How does its category compare?
All FCS devicesFCS Light, Catheter, Fiberoptic, Glass, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCS
1in 2015
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCS
3in 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?
The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038" guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061548 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061548: Stryker Ureteral Illumination System IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061548
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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