510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Hanaulux 2005 Surgical Light

K932451510(k) TraditionalCleared Nov 12, 1993176-day reviewClass II21 CFR 878.4580Recalls 1

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

Heraeus Instruments GmbH · FTD Lamp, Surgical

Cleared on Nov 12, 1993 after a 176-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided
Nov 12, 1993
Review
176 days
Class
Class II
Product code
FTD
Recalls
1
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K932451Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 8, 2023Class IIZ-0768-2024Equipment maintenanceA potential for a light system to fall in the operating room.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FTD devices

FTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTD

3in 2013

2007: 12010: 22011: 12013: 3
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTD

70in 2013

2013: 70 days median
2007high 70 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTD

6in 2023

2007: 112009: 92010: 32016: 12023: 6
2007high 11 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTD

81in 2025

2007: 72008: 102009: 222010: 212011: 302012: 262013: 292014: 292015: 452016: 182017: 102018: 162019: 802020: 1052021: 652022: 1362023: 2512024: 1442025: 81
2007high 251 (2023) · low 7 (2007)2025

MAUDE reports naming product code FTD, 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—117
20080—010
20090—922
20102—321
20111—030
20120—026
2013370029
20140—029
20150—045
20160—118
20170—010
20180—016
20190—080
20200—0105
20210—065
20220—0136
20230—6251
20240—0144
20250—081
20260—0—

Recent decisions in FTD

The FTD category page

  • K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013
  • K130513Volista 400; Volista 600Maquet S.A.S. · 201319 recalls
  • K123776Polaris 100/200Drager Medical GmbH · 2013
  • K111020Atricure DissectorAtriCure, Inc. · 2011
  • K100234HM-Lamp IIHillusa, Inc. · 2010

https://510kreport.com/device/K932451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932451: Hanaulux 2005 Surgical Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932451

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