510(k) Report

510(k) · Cleared

Cleared

Acueity Medical Light Source

K032430510(k) TraditionalCleared Sep 5, 200330-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

Acueity, Inc. · FCW Light Source, Fiberoptic, Routine

Cleared on Sep 5, 2003 as substantially equivalent to K951647 (Welch Allyn, Inc., 1995) after a 30-day review. Its family tree reaches back 1 generation to 1995.

Decided
Sep 5, 2003
Review
30 days
Class
Class II
Product code
FCW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K951647 (1995). No later device cites it as a predicate yet.

K951647 · Welch Allyn HI - Lux Illuminator · Welch Allyn, Inc. · 199519961998200020022004
K951647 · Welch Allyn HI - Lux Illuminator · Welch Allyn, Inc. · 19950
  1. Root · 1 generation backK951647 Welch Allyn HI - Lux IlluminatorWelch Allyn, Inc. · 1995
  2. This deviceK032430 Acueity Medical Light SourceAcueity, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K951647Welch Allyn HI - Lux IlluminatorWelch Allyn, Inc.1995—
0 (this device)K032430Acueity Medical Light SourceAcueity, Inc.2003—
FIG. 1 — Lineage of K032430, 1995–2003Source: 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K951647Welch Allyn HI - Lux Illuminator
Summary page 2
…es. G. Substantial Equivalence The Acuiety Light Source and Video Camera System is substantially equivalent to the Welch Allyn Illumination Platform (K951647). The Medical Light Source is substantially equivalent to the predicate device in intended use, technological chara…
Welch Allyn, Inc.1995—

Also cleared against K951647: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K951647.

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.

FDA decisions per year · FCW

1in 2014

2008: 22009: 12010: 12012: 22013: 12014: 1
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

2011: 4
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

2007: 32008: 22009: 1482010: 7132011: 6032012: 772013: 292014: 112015: 242016: 292017: 592018: 762019: 1182020: 1522021: 1472022: 1662023: 1792024: 1792025: 140
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20082—02
20091—0148
20101—0713
20110—4603
20122—077
20131—029
20141—011
20150—024
20160—029
20170—059
20180—076
20190—0118
20200—0152
20210—0147
20220—0166
20230—0179
20240—0179
20250—0140
20260—0—

What is it indicated for?

The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K951647

1 other device cites the same predicate.

  • K970598Integrated Visualization SystemUrohealth, Inc. · 1997

More from Acueity, Inc.

4 FDA decisions under this applicant name. See the company

  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K032847Excisor Bioptome, Model 01-0004Acueity, Inc. · 2003
  • K011189Viaduct Microendoscope and AccessoriesAcueity, Inc. · 2001

Recent decisions in FCW

The FCW category page

  • K131226Novaprobe Led Light SourceNovaprobe Incorporated · 2014
  • K123956Power Led 175KARL STORZ Endoscopy-America, Inc. · 2013
  • K123359OVS1 Video SystemOlive Medical Corp. · 2012
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K093792Led Light SourceSunoptic Technologies, LLC · 2010

https://510kreport.com/device/K032430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032430: Acueity Medical Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032430

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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