510(k) · Cleared
ClearedScintillant Surgical Light, Model 2644-01-0001
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 Jun 20, 2007 as substantially equivalent to K041681 (AtriCure, Inc., 2004) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 20, 2007
- Review
- 51 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961122 (1996). 6 ancestors in all, the oldest K840371 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961122 Stryker KnifelightStryker Instruments · 1996
- 1 generation backK041681 Atricure DissectorAtriCure, Inc. · 2004
- This deviceK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
- Descendant · cites it directly · 0 of its ownK133425 Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight…Engineered Medical Solutions Co., LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961122 | Stryker Knifelight | Stryker Instruments | 1996 | — |
| −1 | K041681 | Atricure Dissector | AtriCure, Inc. | 2004 | — |
| 0 (this device) | K071180 | Scintillant Surgical Light, Model 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K041681 | Atricure DissectorSummary page 1…cal light, Surgical illuminator Device classification name: FTD, 21 CFR Part 878.4580, Surgical Lamp. Legally marketed devices AtriCure Dissector, K041681 to which the device is Light Port Surgical Illuminator, K041621 substantially equivalent: VersaLight Mul… | 2004 |
| * | K041621 | Liteport LP100 Surgical IlluminatorSummary page 1…CFR Part 878.4580, Surgical Lamp. Legally marketed devices AtriCure Dissector, K041681 to which the device is Light Port Surgical Illuminator, K041621 substantially equivalent: VersaLight Multi-Function Surgical Illuminator, Class I… | 2004 |
| * | — | VersaLight Multi-Function Surgical Illuminator Named without a submission number | |
| * | — | LightMat Surgical Illuminator Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light | 2013 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133425 (Engineered Medical Solutions Co., LLC, 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041681.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Light is intended to provide localized illumination of surgical sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071180: Scintillant Surgical Light, Model 2644-01-0001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071180
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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