510(k) Report

510(k) · Cleared

Cleared

Aculux, Model AX3001, AX3002

K001223510(k) TraditionalCleared Jun 23, 200067-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

Aculux · FQP Lamp, Operating-Room

Cleared on Jun 23, 2000 after a 67-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 23, 2000
Review
67 days
Class
Class II
Product code
FQP
Recalls
None
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 K001223Source: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FQP devices

FQP Lamp, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQP

FDA has decided no FQP device since 2007.

Median 510(k) review, days · FQP

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

Recalls per year · FQP

No recall names FQP since 2007.

Adverse event reports per year · FQP

19in 2025

2008: 12009: 22010: 12011: 42012: 232013: 132014: 62015: 42016: 42017: 52018: 182019: 12020: 192021: 12022: 22023: 72024: 12025: 19
2007high 23 (2012) · low 0 (2007)2025

MAUDE reports naming product code FQP, 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—01
20090—02
20100—01
20110—04
20120—023
20130—013
20140—06
20150—04
20160—04
20170—05
20180—018
20190—01
20200—019
20210—01
20220—02
20230—07
20240—01
20250—019
20260—0—

Recent decisions in FQP

The FQP category page

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  • K770812Handles, Light, Surgical, SteoileSybron Corp. · 1977
  • K761018Surgical Light - Challenge 22 SeriesAmsco Co. · 1977

https://510kreport.com/device/K001223 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001223: Aculux, Model AX3001, AX3002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001223

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