510(k) Report

510(k) · Cleared

Cleared

Flexible Illuminator 5

K840371510(k) TraditionalCleared Apr 24, 198488-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

Suncoast Medical Manufacturers, Inc. · FTF Illuminator, Non-Remote

Cleared on Apr 24, 1984 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 24, 1984
Review
88 days
Class
Class II
Product code
FTF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2013: 1 descendant cleared19801990200020102020
  1. This deviceK840371 Flexible Illuminator 5Suncoast Medical Manufacturers, Inc. · 1984
  2. Descendant · cites it directly · 2 of its ownK041621 Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc. · 2004
  3. Descendant · 2 generations on · 1 of its ownK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
  4. Descendant · 3 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 3 of 3 · See all
  • K041621Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc. · 2004 · cites it directly2descendants
  • K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007 · 2 generations on1descendant
  • K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K840371Flexible Illuminator 5Suncoast Medical Manufacturers, Inc.1984—
+1K041621Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc.2004—
+2K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC2007—
+3K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip…Engineered Medical Solutions Co., LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
201310
FIG. 1 — Lineage of K840371, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K041621Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc.20042

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, K041621 (Medical Vision Industries, Inc., 2004) has gone furthest, with 2 descendants 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—

More from Suncoast Medical Manufacturers, Inc.

31 FDA decisions under this applicant name. See the company

  • K841604Adjust-a-Temp High TemperatureSuncoast Medical Manufacturers, Inc. · 1984
  • K841459Replace-a-Tip Adjust. Low Temp.-Suncoast Medical Manufacturers, Inc. · 1984
  • K841509Replace-a-Tip Adjustable High Temp.Suncoast Medical Manufacturers, Inc. · 1984
  • K841603Adjust-a-Temp MicroSuncoast Medical Manufacturers, Inc. · 1984
  • K841591Pyro-TipSuncoast Medical Manufacturers, Inc. · 1984

Recent decisions in FTF

The FTF category page

  • K041621Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc. · 2004
  • K840373Flexible Illuminator 10Suncoast Medical Manufacturers, Inc. · 1984
  • K840372Flexible Illuminator 15Suncoast Medical Manufacturers, Inc. · 1984

https://510kreport.com/device/K840371 · printed Nov 4, 2026

Cite this page

510(k) Report. “K840371: Flexible Illuminator 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K840371

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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