510(k) Report

510(k) · Cleared

Cleared

Dual Led Lite Engine with Illumination Led Cable Coupled to a Led Lite Head

K042382510(k) TraditionalCleared Nov 30, 200490-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

Med-General Technologies, LLC · FSY Light, Surgical, Ceiling Mounted

Cleared on Nov 30, 2004 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Nov 30, 2004
Review
90 days
Class
Class II
Product code
FSY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK042382 Dual Led Lite Engine with Illumination Led Cable Coupled to a Led…Med-General Technologies, LLC · 2004
  2. Descendant · cites it directly · 1 of its ownK060802 Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K060802Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006 · cites it directly1descendant
  • K132747Visum Blade Led Surgical Lighting SystemStryker Communications · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042382Dual Led Lite Engine with Illumination Led Cable Coupled to a Led Lite HeadMed-General Technologies, LLC2004—
+1K060802Visum Led Surgical Lighting SystemStryker Communications Corp.20064
+2K132747Visum Blade Led Surgical Lighting SystemStryker Communications2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201310
FIG. 1 — Lineage of K042382, 2004–2013Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K060802Visum Led Surgical Lighting SystemStryker Communications Corp.20061

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, K060802 (Stryker Communications Corp., 2006) has gone furthest, with 1 descendant 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?

Illumination in body cavities during examinations or minimal invasive surgical procedures.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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/K042382 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042382: Dual Led Lite Engine with Illumination Led Cable Coupled to a Led Lite Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042382

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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