510(k) Report

510(k) · Cleared

Cleared

Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8

K003489510(k) TraditionalCleared Feb 2, 200181-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

Medical Illumination International, Inc. · FSS Light, Surgical, Floor Standing

Cleared on Feb 2, 2001 after an 81-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Feb 2, 2001
Review
81 days
Class
Class II
Product code
FSS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared200020052010201520202025
  1. This deviceK003489 Next General M20 Surgical Light; Next Generation M16 Minor Surgery…Medical Illumination International, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK100702 Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to…Huot Instruments, LLC · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K100702Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X…Huot Instruments, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K003489, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FSS? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K100702Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X…Huot Instruments, LLC20100

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, K100702 (Huot Instruments, LLC, 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FSS devices

FSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSS

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FSS

Too few FSS 510(k)s in any year since 2007 to give a median.

Recalls per year · FSS

No recall names FSS since 2007.

Adverse event reports per year · FSS

3in 2025

2009: 32010: 32011: 12012: 32013: 112014: 142015: 102016: 22017: 22019: 132020: 92021: 52022: 32023: 152024: 112025: 3
2007high 15 (2023) · low 0 (2007)2025

MAUDE reports naming product code FSS, 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
20070—00
20080—00
20091—03
20100—03
20110—01
20120—03
20130—011
20140—014
20150—010
20160—02
20170—02
20180—00
20190—013
20200—09
20210—05
20220—03
20230—015
20240—011
20250—03
20260—0—

More from Medical Illumination International, Inc.

5 FDA decisions under this applicant name. See the company

  • K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
  • K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
  • K053227Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights, Spotlights, Refractors and…Medical Illumination International, Inc. · 2006
  • K010495Centura Phototherapy SpotlightMedical Illumination International, Inc. · 2001

Recent decisions in FSS

The FSS category page

  • K091246Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)Trumpf Medizin Systeme GmbH + Co. KG · 2009
  • K984124Aesculap Xenon Light SourceAesculap, Inc. · 1999
  • K981962Cuda Products Corp. Model M300 (M-300) LightsourceCuda Products Co. · 1998
  • K981821Ves 3001/2 Dual Output Video IlluminatorAngiolaz, Inc. · 1998
  • K981469CERMAX300 LightsourceCuda Products Co. · 1998

https://510kreport.com/device/K003489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003489: Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003489

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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