510(k) Report

510(k) · Cleared

Recalled · 2007

Skytron Infinity Series Surgical Lights

K915285510(k) TraditionalCleared Feb 20, 199287-day reviewClass II21 CFR 878.4580Recalls 11

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

Skytron, Div. the Kmw Group, Inc. · FSY Light, Surgical, Ceiling Mounted

Cleared on Feb 20, 1992 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 11 times.

Decided
Feb 20, 1992
Review
87 days
Class
Class II
Product code
FSY
Recalls
11
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K915285Source: FDA 510(k) database · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 8, 2007Not classifiedZ-0524-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0530-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0533-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0526-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0534-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0525-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0527-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0528-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0529-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0531-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Jan 8, 2007Not classifiedZ-0532-2007OtherIf the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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 Skytron, Div. the Kmw Group, Inc.

19 FDA decisions under this applicant name. See the company

  • K071698Aurora Led Series Surgical LightsSkytron, Div. the Kmw Group, Inc. · 20074 recalls
  • K021585Stellar Series Surgical Lights with HermesSkytron, Div. the Kmw Group, Inc. · 2002
  • K002463StellarSkytron, Div. the Kmw Group, Inc. · 2000
  • K992090Millennium GoldSkytron, Div. the Kmw Group, Inc. · 1999
  • K950192Skytron Skyboom SeriesSkytron, Div. the Kmw Group, Inc. · 19954 recalls

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/K915285 · printed Nov 4, 2026

Cite this page

510(k) Report. “K915285: Skytron Infinity Series Surgical Lights.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915285

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