510(k) Report

510(k) · Cleared

Cleared

Karl Storz Xenon Light Source Model 201320-20

K934559510(k) TraditionalCleared Apr 22, 1994218-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. · GCT Light Source, Endoscope, Xenon Arc

Cleared on Apr 22, 1994 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 22, 1994
Review
218 days
Class
Class II
Product code
GCT
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared1999: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK934559 Karl Storz Xenon Light Source Model 201320-20KARL STORZ Endoscopy-America, Inc. · 1994
  2. Descendant · cites it directly · 2 of its ownK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
  3. Descendant · cites it directly · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
  4. Descendant · 2 generations on · 0 of its ownK032545 Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180…Mgb Endoskopische Gerate GmbH (Berlin) · 2003
  5. Descendant · cites it directly · 0 of its ownK984124 Aesculap Xenon Light SourceAesculap, Inc. · 1999

Most influential descendants

Showing 4 of 4 · See all
  • K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002 · cites it directly2descendants
  • K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003 · cites it directly1descendant
  • K032545Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250Mgb Endoskopische Gerate GmbH (Berlin) · 2003 · 2 generations on0descendants
  • K984124Aesculap Xenon Light SourceAesculap, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934559Karl Storz Xenon Light Source Model 201320-20KARL STORZ Endoscopy-America, Inc.1994—
+1K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH2002—
+1K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH2003—
+2K032545Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med…Mgb Endoskopische Gerate GmbH (Berlin)2003—
+1K984124Aesculap Xenon Light SourceAesculap, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200320
FIG. 1 — Lineage of K934559, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCT? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH20022
K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH20031
K984124Aesculap Xenon Light SourceAesculap, Inc.19990

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?

  • Of its descendants, K020889 (World of Medicine Lemke GmbH, 2002) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GCT devices

GCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCT

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCT

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

Recalls per year · GCT

No recall names GCT since 2007.

Adverse event reports per year · GCT

347in 2025

2007: 322008: 292009: 1532010: 212011: 1322012: 362013: 72014: 112015: 82016: 152017: 142018: 202019: 182020: 1142021: 1492022: 1582023: 2002024: 2962025: 347
2007high 347 (2025) · low 7 (2013)2025

MAUDE reports naming product code GCT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—032
20081—029
20090—0153
20101—021
20110—0132
20120—036
20130—07
20140—011
20150—08
20160—015
20170—014
20180—020
20190—018
20200—0114
20210—0149
20220—0158
20230—0200
20240—0296
20250—0347
20260—0—

More from KARL STORZ Endoscopy-America, Inc.

381 FDA decisions under this applicant name. See the company

  • P050027/S038Photodynamic Diagnostic D-Light C SystemKARL STORZ Endoscopy-America, Inc. · 2026
  • P050027/S036Photodynamic Diagnostic D-Light C SystemKARL STORZ Endoscopy-America, Inc. · 2026
  • K252624KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2026
  • P050027/S035Photodynamic Diagnostic D-Light C (PDD) SystemKARL STORZ Endoscopy-America, Inc. · 2026
  • P050027/S034Photodynamic Diagnostic D-Light C SystemKARL STORZ Endoscopy-America, Inc. · 2025

Recent decisions in GCT

The GCT category page

  • K093125Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
  • K082925Xenon-100 SCB Light Source, Model 20132620KARL STORZ Endoscopy-America, Inc. · 2008
  • K070376Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 20072 recalls
  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K022490Ksea Medi PackKARL STORZ Endoscopy-America, Inc. · 2003

https://510kreport.com/device/K934559 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934559: Karl Storz Xenon Light Source Model 201320-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934559

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026