510(k) Report

510(k) · Cleared

Cleared

Shampaine 1000 Series Angenieux AX-14 Duo,AX-4

K904965510(k) TraditionalCleared Jan 16, 199172-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

Smith & Nephew Equipment Group · FSY Light, Surgical, Ceiling Mounted

Cleared on Jan 16, 1991 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Jan 16, 1991
Review
72 days
Class
Class II
Product code
FSY
Recalls
None
Predicates
0

16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 2 descendants cleared2010: 3 descendants cleared2012: 2 descendants cleared2014: 4 descendants cleared2013: 3 descendants cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK904965 Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group · 1991
  2. Descendant · cites it directly · 15 of its ownK040735 Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004 · Recalled
  3. Descendant · 2 generations on · 14 of its ownK070442 Powerled Surgical Light SystemMaquet S.A. · 2007 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
  5. Descendant · 3 generations on · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
  6. Descendant · 3 generations on · 2 of its ownK113679 Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2004: 12007: 22009: 12010: 32012: 22013: 32014: 4
2004high 4 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 16 · See all
  • K040735Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004 · cites it directly15descendants
  • K070442Powerled Surgical Light SystemMaquet S.A. · 2007 · 2 generations on14descendants
  • K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · 3 generations on10descendants
  • K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · 3 generations on4descendants
  • K113679Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904965Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group1991—
+1K040735Alm X'ten (X10) Surgical Light SystemAlm S.A.20046
+2K070442Powerled Surgical Light SystemMaquet S.A.20073
+3K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation20071
+3K093009Mach Led SCDr. Mach GmbH & Co. KG2010—
+3K113679Lucea Led Surgical Light SystemMaquet S.A.S.20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200720
200910
201030
201220
201330
201440
FIG. 1 — Lineage of K904965, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K040735Alm X'ten (X10) Surgical Light SystemAlm S.A.200415

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?

  • Of its descendants, K040735 (Alm S.A., 2004) has gone furthest, with 15 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—

More from Smith & Nephew Equipment Group

2 FDA decisions under this applicant name. See the company

  • K910783Shampaine Model 3800 or Muranaka Model or-604MSmith & Nephew Equipment Group · 1991

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/K904965 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904965: Shampaine 1000 Series Angenieux AX-14 Duo,AX-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904965

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