510(k) Report

510(k) · Cleared

Cleared

Halux Iris Examination and Surgical Lamp

K053364510(k) TraditionalCleared Feb 23, 200683-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

Waldmann Lighting · FTD Lamp, Surgical

Cleared on Feb 23, 2006 as substantially equivalent to K042395 (Burton Medical Products Corp., 2004) after an 83-day review. Its family tree reaches back 1 generation to 2004.

Decided
Feb 23, 2006
Review
83 days
Class
Class II
Product code
FTD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K042395 (2004). No later device cites it as a predicate yet.

K042395 · Outpatient Iii Minor Surgery Light · Burton Medical Products Corp. · 200420002002200420062008
K042395 · Outpatient Iii Minor Surgery Light · Burton Medical Products Corp. · 20040
  1. Root · 1 generation backK042395 Outpatient Iii Minor Surgery LightBurton Medical Products Corp. · 2004
  2. This deviceK053364 Halux Iris Examination and Surgical LampWaldmann Lighting · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K042395Outpatient Iii Minor Surgery LightBurton Medical Products Corp.2004—
0 (this device)K053364Halux Iris Examination and Surgical LampWaldmann Lighting2006—
FIG. 1 — Lineage of K053364, 2004–2006Source: 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), 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 FTD? 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? (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
*K042395Outpatient Iii Minor Surgery Light
Summary page 1
…urgical Codes FID and FSY.. Common/Usual Name: Surgical lamp 2. Equivalent legally marketed devices Burton Medical Products Corp Outpatient* Minor Surgical Light, K042395 3. Indications for Use (intended use) Halux® hris is designed to provide the required illumination for surgeries, procedures,…
Burton Medical Products Corp.2004—

Also cleared against K042395: 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 K042395.

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—

What is it indicated for?

Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Indications for use as stated in the FDA summary.

Also cleared against K042395

1 other device cites the same predicate.

  • K101537Aim 200, Major Surgical LightBurton Medical Products Corp. · 2010

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/K053364 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053364: Halux Iris Examination and Surgical Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053364

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026