510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Powerled Surgical Light System

K070442510(k) SpecialCleared Mar 16, 200729-day reviewClass II21 CFR 878.4580Recalls 3

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

Maquet S.A. · FSY Light, Surgical, Ceiling Mounted

Cleared on Mar 16, 2007 as substantially equivalent to K040735 (Alm S.A., 2004) after a 29-day review. Its family tree reaches back 2 generations to 1991. 14 later devices descend from it. It has been recalled 3 times.

Decided
Mar 16, 2007
Review
29 days
Class
Class II
Product code
FSY
Recalls
3
Predicates
1

Its longest line of descent runs back 2 generations to K904965 (1991). 14 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared2012: 2 descendants cleared2014: 4 descendants cleared2007: 1 descendant cleared2013: 3 descendants cleared2009: 1 descendant clearedK904965 · Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 · Smith & Nephew Equipment Group · 1991K040735 · Alm X'ten (X10) Surgical Light System · Alm S.A. · 2004 · recalled1990200020102020
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K040735 · Alm X'ten (X10) Surgical Light System · Alm S.A. · 2004 · recalledK904965 · Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 · Smith & Nephew Equipment Group · 19910
  1. Root · 2 generations backK904965 Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group · 1991
  2. 1 generation backK040735 Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004 · Recalled
  3. This deviceK070442 Powerled Surgical Light SystemMaquet S.A. · 2007
  4. Descendant · cites it directly · 10 of its ownK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
  5. Descendant · cites it directly · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
  6. Descendant · cites it directly · 2 of its ownK113679 Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK132307 Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013
  8. Descendant · cites it directly · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 32012: 22013: 32014: 4
2007high 4 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 14 · See all
  • K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · cites it directly10descendants
  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · cites it directly4descendants
  • K113679Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · cites it directly2descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904965Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group1991—
−1K040735Alm X'ten (X10) Surgical Light SystemAlm S.A.20046
0 (this device)K070442Powerled Surgical Light SystemMaquet S.A.2007—
+1K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation20071
+1K093009Mach Led SCDr. Mach GmbH & Co. KG2010—
+1K113679Lucea Led Surgical Light SystemMaquet S.A.S.20121
+2K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation2013—
+1K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201030
201220
201330
201440
FIG. 1 — Lineage of K070442, 1991–2014Source: 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
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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
*K040735Alm X'ten (X10) Surgical Light System
Summary page 1
…n: Surgical Lamp (78 FSY) Class II,as listed per 21 CFR 878.4580 Predicate Device: ALM X'TEN® (X1 0) Surgical Light System (K040735) Description of Device: The POWERLEDTM Surgical Light System is a new product designation intended to identify a family of surgic…
Alm S.A.20046

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation200710
K093009Mach Led SCDr. Mach GmbH & Co. KG20104
K113679Lucea Led Surgical Light SystemMaquet S.A.S.20122
K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc.20101
K132551ZF 720Umbel Corporation20140
K130513Volista 400; Volista 600Maquet S.A.S.20130
K122875Oricare L2700Oricare, Inc.20120

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 7, 2026Class IIZ-3224-2026Process controlThe potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Nov 8, 2023Class IIZ-0763-2024Equipment maintenanceA potential for a light system to fall in the operating room.
May 29, 2015Class IIZ-1990-2015Device DesignMaquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K072072 (STERIS Corporation, 2007) has gone furthest, with 10 descendants of its own.

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?

MAQUET POWERLED™ Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient.

An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination.

An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's head, and to compensate for loss of illumination due to an obstacle in front of the cupola.

Indications for use as stated in the FDA summary.

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/K070442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070442: Powerled Surgical Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070442

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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