510(k) Report

510(k) · Cleared

Cleared

Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X Y -N-S-W. X=Number of Light Pods

K100702510(k) TraditionalCleared Jul 20, 2010130-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

Huot Instruments, LLC · FSY Light, Surgical, Ceiling Mounted

Cleared on Jul 20, 2010 as substantially equivalent to K003489 (Medical Illumination International, Inc., 2001) after a 130-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jul 20, 2010
Review
130 days
Class
Class II
Product code
FSY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003489 (2001). No later device cites it as a predicate yet.

K003489 · Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8 · Medical Illumination International, Inc. · 20012000200220042006200820102012
K003489 · Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8 · Medical Illumination International, Inc. · 20010
  1. Root · 1 generation backK003489 Next General M20 Surgical Light; Next Generation M16 Minor Surgery…Medical Illumination International, Inc. · 2001
  2. This deviceK100702 Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to…Huot Instruments, LLC · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…Medical Illumination International, Inc.2001—
0 (this device)K100702Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style)…Huot Instruments, LLC2010—
FIG. 1 — Lineage of K100702, 2001–2010Source: 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? (2)

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
*K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…
Summary page 1
…s listed per 21 CFIR 878.4580 Predicate Device: Next Generation Surgery Light Medical Illumination International K003489 Product Class: FSS, FTD, ESY AIM Burton Medical Produc…
Medical Illumination International, Inc.2001—
*—AIM
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no 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. 2010, 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?

The StarTrol LED Lighting system is designed to provide a visible illumination of the

examination /surgical field of the patient during surgical and non-surgical procedures.

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/K100702 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100702: Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X Y -N-S-W. X=Number of Light Pods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100702

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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