510(k) · Cleared
ClearedScintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Solutions Co., LLC · FTD Lamp, Surgical
Cleared on Dec 5, 2013 as substantially equivalent to K071180 (Engineered Medical Solutions Co., LLC, 2007) after a 27-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Dec 5, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961122 (1996). 7 ancestors in all, the oldest K840371 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK961122 Stryker KnifelightStryker Instruments · 1996
- 2 generations backK041681 Atricure DissectorAtriCure, Inc. · 2004
- 1 generation backK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
- This deviceK133425 Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight…Engineered Medical Solutions Co., LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961122 | Stryker Knifelight | Stryker Instruments | 1996 | — |
| −2 | K041681 | Atricure Dissector | AtriCure, Inc. | 2004 | — |
| −1 | K071180 | Scintillant Surgical Light, Model 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007 | — |
| 0 (this device) | K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip… | Engineered Medical Solutions Co., LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 3 | 0 |
| 2004 | 1 | 0 |
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 FTD? 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071180 | Scintillant Surgical Light, Model 2644-01-0001Summary page 2…Scintillant Dual Straight Tip Surgical Light are substantially equivalent to the predicate Scintillant Surgical Lamp cleared by the FDA in K071180 (SE 06/20/07). Engineered Medical Solutions Co., LLC Page 12 of 30 =… | 2007 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, 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 | 1 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Scintillant Surgical Lights are Intended to provide localized Illumination of surgical sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133425: Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133425
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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