510(k) · Cleared

Cleared

Power Led 175

K123956510(k) TraditionalCleared Jan 25, 201335-day reviewClass II21 CFR 876.1500

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

KARL STORZ Endoscopy-America, Inc. · FCW Light Source, Fiberoptic, Routine

Cleared on Jan 25, 2013 as substantially equivalent to K091968 (KARL STORZ Endoscopy-America, Inc., 2009) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jan 25, 2013
Review: 35 days
Class: Class II
Product code: FCW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K962595 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962595 Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsKARL STORZ Endoscopy-America, Inc. · 1996
This deviceK123956 Power Led 175KARL STORZ Endoscopy-America, Inc. · 2013
Descendant · cites it directly · 0 of its ownK141164 Artemis Light EngineQuest Medical Imaging · 2015

Most influential descendants

Showing 1 of 1 · See all

K141164Artemis Light EngineQuest Medical Imaging · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962595	Karl Storz Xenon 300 Light Source for Non-Flash Applications	KARL STORZ Endoscopy-America, Inc.	1996	—
0 (this device)	K123956	Power Led 175	KARL STORZ Endoscopy-America, Inc.	2013	—
+1	K141164	Artemis Light Engine	Quest Medical Imaging	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K123956, 1996–2015Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K091968	Karl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020C Summary page 3 …mrc -n :Inc. Inc. 510(k) number K1_23956 K09 1968 K962595 Type of Device Ligh 0..o . Light Source Light Source…	KARL STORZ Endoscopy-America, Inc.	2009	—
*	K962595	Karl Storz Xenon 300 Light Source for Non-Flash Applications Summary page 1 …TaePrpitry Name/Model Number I Manufacturer/ K91968 LED NOVA 100 Cold Light Fountain Karl Storz GmbH & Co. KG K962595 300 Watt Xenon Light Source Karl Storz GmbH & Co. KG Introduction: Device Trade Na…	KARL STORZ Endoscopy-America, Inc.	1996	—

Also cleared against K091968: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K141164	Artemis Light Engine	Quest Medical Imaging	2015	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?

None of the 2 ancestors has a recall.
Of its descendants, K141164 (Quest Medical Imaging, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K091968.

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. 2013, 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?

Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123956 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123956: Power Led 175.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123956

Report an extraction error

Are you the manufacturer?

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