510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Alm X'ten (X10) Surgical Light System

K040735510(k) SpecialCleared May 21, 200460-day reviewClass II21 CFR 878.4580Recalls 6

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

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

Cleared on May 21, 2004 as substantially equivalent to K904965 (Smith & Nephew Equipment Group, 1991) after a 60-day review. Its family tree reaches back 1 generation to 1991. 15 later devices descend from it. It has been recalled 6 times.

Decided
May 21, 2004
Review
60 days
Class
Class II
Product code
FSY
Recalls
6
Predicates
1

Its longest line of descent runs back 1 generation to K904965 (1991). 15 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2010: 3 descendants cleared2012: 2 descendants cleared2014: 4 descendants cleared2013: 3 descendants cleared2009: 1 descendant clearedK904965 · Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 · Smith & Nephew Equipment Group · 19911990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant K904965 · Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 · Smith & Nephew Equipment Group · 19910
  1. Root · 1 generation backK904965 Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group · 1991
  2. This deviceK040735 Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004
  3. Descendant · cites it directly · 14 of its ownK070442 Powerled Surgical Light SystemMaquet S.A. · 2007 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
  6. Descendant · 2 generations on · 2 of its ownK113679 Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · Recalled
  7. Descendant · 3 generations on · 1 of its ownK132307 Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007: 22009: 12010: 32012: 22013: 32014: 4
2007high 4 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 15 · See all
  • K070442Powerled Surgical Light SystemMaquet S.A. · 2007 · cites it directly14descendants
  • K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · 2 generations on10descendants
  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · 2 generations on4descendants
  • K113679Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · 2 generations on2descendants
  • K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904965Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group1991—
0 (this device)K040735Alm X'ten (X10) Surgical Light SystemAlm S.A.2004—
+1K070442Powerled Surgical Light SystemMaquet S.A.20073
+2K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation20071
+2K093009Mach Led SCDr. Mach GmbH & Co. KG2010—
+2K113679Lucea Led Surgical Light SystemMaquet S.A.S.20121
+3K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200910
201030
201220
201330
201440
FIG. 1 — Lineage of K040735, 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
*K904965Shampaine 1000 Series Angenieux AX-14 Duo,AX-4
Summary page 1
…n: Surgical Lamp (78 ESY) Class 11,as listed per 21 CFR 878.4580 Predicate Device: ALM Angenieux® (AX) Series Surgical Light [K9049651 Description of Device: The ALM X'Ten TM Surgical Light System is a new product designation intended to identify a family of su…
Smith & Nephew Equipment Group1991—

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070442Powerled Surgical Light SystemMaquet S.A.200714

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 8, 2023Class IIZ-0766-2024Equipment maintenanceA potential for a light system to fall in the operating room.
Nov 16, 2017Class IIZ-1927-2018Unknown/Undetermined by firmGetinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the…
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…
Oct 7, 2009Not classifiedZ-0186-2010Device DesignSeveral reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.
Oct 7, 2009Not classifiedZ-0188-2010Device DesignSeveral reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.
Oct 7, 2009Not classifiedZ-0187-2010Device DesignSeveral reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K070442 (Maquet S.A., 2007) has gone furthest, with 14 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.

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?

ALM X'Ten TM (X10) Surgical Light Systems with Energix TM Power Supply are intended to be used to provide visible illumination of the surgical area or the patient.

An optional "LEDinside" feature is available and produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examinations.

The Energix TM Power Supply is intended for use with surgical light systems.

Indications for use as stated in the FDA summary.

More from Alm S.A.

2 FDA decisions under this applicant name. See the company

  • K040015Modification to Prismalix Surgical LightAlm S.A. · 2004

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/K040735 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040735: Alm X'ten (X10) Surgical Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040735

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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