510(k) Report

510(k) · Cleared

Cleared

Liteport LP100 Surgical Illuminator

K041621510(k) TraditionalCleared Sep 13, 200489-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 Vision Industries, Inc. · FTF Illuminator, Non-Remote

Cleared on Sep 13, 2004 as substantially equivalent to K840371 (Suncoast Medical Manufacturers, Inc., 1984) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.

Decided
Sep 13, 2004
Review
89 days
Class
Class II
Product code
FTF
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K840371 (1984). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1984: 2 other ancestors2007: 1 descendant cleared2013: 1 descendant clearedK840371 · Flexible Illuminator 5 · Suncoast Medical Manufacturers, Inc. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K840371 · Flexible Illuminator 5 · Suncoast Medical Manufacturers, Inc. · 19840
  1. Root · 1 generation backK840371 Flexible Illuminator 5Suncoast Medical Manufacturers, Inc. · 1984
  2. This deviceK041621 Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc. · 2004
  3. Descendant · cites it directly · 1 of its ownK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
  4. Descendant · 2 generations on · 0 of its ownK133425 Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight…Engineered Medical Solutions Co., LLC · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007 · cites it directly1descendant
  • K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K840371Flexible Illuminator 5Suncoast Medical Manufacturers, Inc.1984—
0 (this device)K041621Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc.2004—
+1K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC2007—
+2K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip…Engineered Medical Solutions Co., LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201310
FIG. 1 — Lineage of K041621, 1984–2013Source: 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 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 FTF? 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? (3)

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
*K840371Flexible Illuminator 5
Summary page 2
…ice system identified earlier and marketed by Suncoast Medical Manufacturers: Suncoast Medical Manufacturers, Ine. Flexible Rlluminator; 1840371, K840372, K840373 The Suncoast device is cleared for marketing, having met the requirements for a finding of substantial…
Suncoast Medical Manufacturers, Inc.1984—
*K840372Flexible Illuminator 15
Summary page 2
…em identified earlier and marketed by Suncoast Medical Manufacturers: Suncoast Medical Manufacturers, Ine. Flexible Rlluminator; 1840371, K840372, K840373 The Suncoast device is cleared for marketing, having met the requirements for a finding of substantial equi…
Suncoast Medical Manufacturers, Inc.1984—
*K840373Flexible Illuminator 10
Summary page 2
…fied earlier and marketed by Suncoast Medical Manufacturers: Suncoast Medical Manufacturers, Ine. Flexible Rlluminator; 1840371, K840372, K840373 The Suncoast device is cleared for marketing, having met the requirements for a finding of substantial equivalence o…
Suncoast Medical Manufacturers, Inc.1984—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC20071

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K071180 (Engineered Medical Solutions Co., LLC, 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FTF devices

FTF Illuminator, Non-Remote: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTF

FDA has decided no FTF device since 2007.

Median 510(k) review, days · FTF

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

Recalls per year · FTF

No recall names FTF since 2007.

Adverse event reports per year · FTF

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code FTF, 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
20090—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The LitePort@ LP100 Surgical Illuminator provides supplemental illumination in surgical procedures in the thoracic and abdominal cavities.

Indications for use as stated in the FDA summary.

Recent decisions in FTF

The FTF category page

  • K840373Flexible Illuminator 10Suncoast Medical Manufacturers, Inc. · 1984
  • K840371Flexible Illuminator 5Suncoast Medical Manufacturers, Inc. · 1984
  • K840372Flexible Illuminator 15Suncoast Medical Manufacturers, Inc. · 1984

https://510kreport.com/device/K041621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041621: Liteport LP100 Surgical Illuminator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041621

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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