510(k) Report

510(k) · Cleared

Recalled · 2011

Harmony Led-1 Surgical Lighting System

K072072510(k) TraditionalCleared Oct 5, 200767-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

STERIS Corporation · FSY Light, Surgical, Ceiling Mounted

Cleared on Oct 5, 2007 as substantially equivalent to K070442 (Maquet S.A., 2007) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it. It has been recalled once.

Decided
Oct 5, 2007
Review
67 days
Class
Class II
Product code
FSY
Recalls
1
Predicates
3

Its longest line of descent runs back 3 generations to K965130 (1997). 7 ancestors in all, the oldest K904965 (1991). 10 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2001: 1 other ancestor2004: 1 other ancestor1991: 1 other ancestor2010: 3 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2013: 2 descendants cleared2014: 3 descendants clearedK965130 · Chromophare · Berchtold Holding GmbH · 1997K024132 · Chromophare X 65 · Berchtold Holding GmbH · 2003K061317 · ILED · Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K061317 · ILED · Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · recalledK024132 · Chromophare X 65 · Berchtold Holding GmbH · 2003K965130 · Chromophare · Berchtold Holding GmbH · 19970
  1. Root · 3 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
  2. 2 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
  3. 1 generation backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
  4. This deviceK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007
  5. Descendant · cites it directly · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
  6. Descendant · 2 generations on · 1 of its ownK132307 Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013
  7. Descendant · cites it directly · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
  8. Descendant · 2 generations on · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
  9. Descendant · 3 generations on · 0 of its ownK140930 Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 12010: 32012: 12013: 22014: 3
2009high 3 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 10 · See all
  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · cites it directly4descendants
  • K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013 · 2 generations on1descendant
  • K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010 · cites it directly1descendant
  • K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014 · 2 generations on0descendants
  • K140930Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K965130ChromophareBerchtold Holding GmbH1997—
−2K024132Chromophare X 65Berchtold Holding GmbH2003—
−1K061317ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg20067
0 (this device)K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation2007—
+1K093009Mach Led SCDr. Mach GmbH & Co. KG2010—
+2K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation2013—
+1K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc.2010—
+2K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc.2014—
+3K140930Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200110
200410
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201030
201210
201320
201430
FIG. 1 — Lineage of K072072, 1997–2014Source: 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 FSY? 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? (3)

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
*K070442Powerled Surgical Light System
Summary page 1
…878.4580 Product Code: FSY 2. Predicate Devices * POWERLED Tm Surgical Light System cleared for market on March 16, 2007 as K070442 (Getinge USA, Inc). * iLED cleared for market on June 22, 2006 as K061317 (Trumpf Kreuzer Medizin). * Amsc…
Maquet S.A.20073
*K061317ILED
Summary page 1
…* POWERLED Tm Surgical Light System cleared for market on March 16, 2007 as K070442 (Getinge USA, Inc). * iLED cleared for market on June 22, 2006 as K061317 (Trumpf Kreuzer Medizin). * Amsco Harmony Surgical Lighting and Media System cleared for market on Decem…
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg20067
*K013242Amsco Harmony Surgical Lighting and Media System
Summary page 1
…June 22, 2006 as K061317 (Trumpf Kreuzer Medizin). * Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation). 3. Device Description The proposed Harmony LED-I Surgical Lighting System subjected in this…
STERIS Corporation20014

Also cleared against K070442: 6 other devices →

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093009Mach Led SCDr. Mach GmbH & Co. KG20104
K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc.20101
K122875Oricare L2700Oricare, Inc.20120
K100395Harmony Vled Surgical Lightning SystemSTERIS Corporation20100
K083323Nuvo Verde Led Lighting SystemNuvo, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 18, 2011Not classifiedZ-1886-2011OtherThe arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
  • 4 of the 7 ancestors have a recall of any class.
  • Of its descendants, K093009 (Dr. Mach GmbH & Co. KG, 2010) has gone furthest, with 4 descendants of its own.
  • 6 other devices also cite its predicate K070442.

How does its category compare?

All FSY devices

FSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FSY

7in 2014

2007: 32008: 22009: 22010: 52012: 22013: 32014: 7
2007high 7 (2014) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FSY

59in 2014

2007: 29 days median2010: 130 days median2013: 118 days median2014: 59 days median
2007high 130 (2010) · low 29 (2007)2026

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

Recalls per year · FSY

11in 2023

2009: 42010: 32011: 42012: 42013: 12015: 2282018: 22019: 42023: 112026 (partial year): 4
2007high 228 (2015) · low 0 (2007)2026

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

Adverse event reports per year · FSY

286in 2025

2007: 702008: 532009: 402010: 722011: 702012: 1712013: 1372014: 1392015: 1752016: 1822017: 1622018: 3162019: 4442020: 4392021: 3802022: 4302023: 6632024: 5412025: 286
2007high 663 (2023) · low 40 (2009)2025

MAUDE reports naming product code FSY, 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
2007329070
20082—053
20092—440
20105130372
20110—470
20122—4171
201331181137
20147590139
20150—228175
20160—0182
20170—0162
20180—2316
20190—4444
20200—0439
20210—0380
20220—0430
20230—11663
20240—0541
20250—0286
20260—4—

What is it indicated for?

The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K070442

6 other devices cite the same predicate.

  • K132551ZF 720Umbel Corporation · 2014
  • K130513Volista 400; Volista 600Maquet S.A.S. · 201319 recalls
  • K122875Oricare L2700Oricare, Inc. · 2012
  • K113679Lucea Led Surgical Light SystemMaquet S.A.S. · 20121 recall
  • K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010

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Recent decisions in FSY

The FSY category page

  • K142984Leo MinorSunnex, Inc. · 2014
  • K142076Claveguard Freedom Surgical LightDickson & Dickson Healthcare (Us), Inc. · 2014
  • K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
  • K132551ZF 720Umbel Corporation · 2014
  • K140930Vida Led Surgical Lighting System, V SeriesConvida Healthcare & Systems Corporation · 2014

https://510kreport.com/device/K072072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072072: Harmony Led-1 Surgical Lighting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072072

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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