510(k) · Cleared
ClearedFlexible Illuminator 15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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. 5 later devices descend from it.
- Decided
- Apr 24, 1984
- Review
- 88 days
- Class
- Class II
- Product code
- FTF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK840372 Flexible Illuminator 15Suncoast Medical Manufacturers, Inc. · 1984
- Descendant · cites it directly · 2 of its ownK041621 Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)…Applied Medical Resources Corporation · 2026
- Descendant · 2 generations on · 1 of its ownK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
- Descendant · 2 generations on · 0 of its ownK260982 Alexis lighted wound protector-retractor, flexible, extra small…Applied Medical Resources Corporation · 2026
- 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 5 of 5 · See all- K041621Liteport LP100 Surgical IlluminatorMedical Vision Industries, Inc. · 2004 · cites it directly2descendants
- K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…Applied Medical Resources Corporation · 2026 · cites it directly1descendant
- K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007 · 2 generations on1descendant
- K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…Applied Medical Resources Corporation · 2026 · 2 generations on0descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840372 | Flexible Illuminator 15 | Suncoast Medical Manufacturers, Inc. | 1984 | — |
| +1 | K041621 | Liteport LP100 Surgical Illuminator | Medical Vision Industries, Inc. | 2004 | — |
| +1 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis®… | Applied Medical Resources Corporation | 2026 | — |
| +2 | K071180 | Scintillant Surgical Light, Model 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007 | — |
| +2 | K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis… | Applied Medical Resources Corporation | 2026 | — |
| +3 | K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip… | Engineered Medical Solutions Co., LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2026 | 2 | 0 |
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
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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesFTF 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
MAUDE reports naming product code FTF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K840372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K840372: Flexible Illuminator 15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840372
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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