510(k) Report

510(k) · Cleared

Cleared

Aesculap Xenon Light Source

K984124510(k) TraditionalCleared Feb 1, 199975-day reviewClass II21 CFR 878.4580

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

Aesculap, Inc. · FSS Light, Surgical, Floor Standing

Cleared on Feb 1, 1999 as substantially equivalent to K980044 (Perkinelmer Optoelectronics, 1998) and 2 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1994.

Decided
Feb 1, 1999
Review
75 days
Class
Class II
Product code
FSS
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K934559 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1995: 1 other ancestorK934559 · Karl Storz Xenon Light Source Model 201320-20 · KARL STORZ Endoscopy-America, Inc. · 1994199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K934559 · Karl Storz Xenon Light Source Model 201320-20 · KARL STORZ Endoscopy-America, Inc. · 19940
  1. Root · 1 generation backK934559 Karl Storz Xenon Light Source Model 201320-20KARL STORZ Endoscopy-America, Inc. · 1994
  2. This deviceK984124 Aesculap Xenon Light SourceAesculap, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934559Karl Storz Xenon Light Source Model 201320-20KARL STORZ Endoscopy-America, Inc.1994—
0 (this device)K984124Aesculap Xenon Light SourceAesculap, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
FIG. 1 — Lineage of K984124, 1994–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 FSS? 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K980044Xenon 300MX
Summary page 2
…ilization. - Substantial Equivalence Aesculap’s Xenon Light Source shares similar features and function with corresponding devices distributed by: EG&G Electro-Optics (K980044) Lutex (K890716) Karl Storz (K934559) Wolf (K952696) SERV; v Cl;,b o *, oY, o ) {é DEPARTMENT OF HEALTH & HU…
Perkinelmer Optoelectronics1998—
Kept off the family treeK890716FDA’s K890716 is Luxtec Aco Series 4000 Light Source
Our OCR of the scanned summary read K890716, FDA’s number for Luxtec Aco Series 4000 Light Source (Luxtec Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lutex”. Kept off the family tree.
Summary page 2
…bstantial Equivalence Aesculap’s Xenon Light Source shares similar features and function with corresponding devices distributed by: EG&G Electro-Optics (K980044) Lutex (K890716) Karl Storz (K934559) Wolf (K952696) SERV; v Cl;,b o *, oY, o ) {é DEPARTMENT OF HEALTH & HUMAN SERVICES Pub…
Luxtec Corp.1989—
*K934559Karl Storz Xenon Light Source Model 201320-20
Summary page 2
…Aesculap’s Xenon Light Source shares similar features and function with corresponding devices distributed by: EG&G Electro-Optics (K980044) Lutex (K890716) Karl Storz (K934559) Wolf (K952696) SERV; v Cl;,b o *, oY, o ) {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service p-…
KARL STORZ Endoscopy-America, Inc.1994—
*K952696Xenon Light Source Model 5121
Summary page 2
…on Light Source shares similar features and function with corresponding devices distributed by: EG&G Electro-Optics (K980044) Lutex (K890716) Karl Storz (K934559) Wolf (K952696) SERV; v Cl;,b o *, oY, o ) {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service p- Food and Drug…
Richard Wolf Medical Instruments Corp.1995—

What descends from it?

No later submission names this one as a predicate yet.

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 3 ancestors has a recall.

How does its category compare?

All FSS devices

FSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSS

1in 2009

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

2026 to Oct 25, outlined.

Median 510(k) review, days · FSS

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

Recalls per year · FSS

No recall names FSS since 2007.

Adverse event reports per year · FSS

3in 2025

2009: 32010: 32011: 12012: 32013: 112014: 142015: 102016: 22017: 22019: 132020: 92021: 52022: 32023: 152024: 112025: 3
2007high 15 (2023) · low 0 (2007)2025

MAUDE reports naming product code FSS, 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
20070—00
20080—00
20091—03
20100—03
20110—01
20120—03
20130—011
20140—014
20150—010
20160—02
20170—02
20180—00
20190—013
20200—09
20210—05
20220—03
20230—015
20240—011
20250—03
20260—0—

What is it indicated for?

Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contain fiberoptic bundles. lilumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.

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

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

Recent decisions in FSS

The FSS category page

  • K091246Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)Trumpf Medizin Systeme GmbH + Co. KG · 2009
  • K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next…Medical Illumination International, Inc. · 2001
  • K981962Cuda Products Corp. Model M300 (M-300) LightsourceCuda Products Co. · 1998
  • K981821Ves 3001/2 Dual Output Video IlluminatorAngiolaz, Inc. · 1998
  • K981469CERMAX300 LightsourceCuda Products Co. · 1998

https://510kreport.com/device/K984124 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984124: Aesculap Xenon Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984124

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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