510(k) · Cleared
Recalled · Class II · 2023Lucea Led Surgical Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet S.A.S. · NTN Led Light Source
Cleared on Jan 12, 2012 as substantially equivalent to K070442 (Maquet S.A., 2007) and 2 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- NTN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904965 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK904965 Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group · 1991
- 2 generations backK040735 Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004 · Recalled
- 1 generation backK070442 Powerled Surgical Light SystemMaquet S.A. · 2007 · Recalled
- This deviceK113679 Lucea Led Surgical Light SystemMaquet S.A.S. · 2012
- Descendant · cites it directly · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK130513 Volista 400; Volista 600Maquet S.A.S. · 2013 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904965 | Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 | Smith & Nephew Equipment Group | 1991 | — |
| −2 | K040735 | Alm X'ten (X10) Surgical Light System | Alm S.A. | 2004 | 6 |
| −1 | K070442 | Powerled Surgical Light System | Maquet S.A. | 2007 | 3 |
| 0 (this device) | K113679 | Lucea Led Surgical Light System | Maquet S.A.S. | 2012 | — |
| +1 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
| +1 | K130513 | Volista 400; Volista 600 | Maquet S.A.S. | 2013 | 19 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 NTN? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070442 | Powerled Surgical Light SystemSummary page 1…ce classification Class 11,acording to regulation number 21 CFR 878.4580 Predicate Device identification 9 MAQUET POWERLED TM Surgical Light System - 51 0(k) No. K070442 * MAQUET BLUE 30 & 80 Surgical Light System (ceiling mounted) - 510(k) No. K954169 e MAQUET BLUE 80 Hospital Surgical Light… | 2007 |
| * | K954169 | Hanaulux Blue 30 & 80Summary page 1…e Device identification 9 MAQUET POWERLED TM Surgical Light System - 51 0(k) No. K070442 * MAQUET BLUE 30 & 80 Surgical Light System (ceiling mounted) - 510(k) No. K954169 e MAQUET BLUE 80 Hospital Surgical Light System (floor standing) - 510(k) No. K970886… | 1996 |
| * | K970886 | Hanaulux Blue 80 HospitalSummary page 1…42 * MAQUET BLUE 30 & 80 Surgical Light System (ceiling mounted) - 510(k) No. K954169 e MAQUET BLUE 80 Hospital Surgical Light System (floor standing) - 510(k) No. K970886 37… | 1997 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2023 | Class II | Z-0759-2024 | Equipment maintenance | A potential for a light system to fall in the operating room. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K140812 (Medical Illumination International, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K070442.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NTN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NTN
Too few NTN 510(k)s in any year since 2007 to give a median.
Recalls per year · NTN
No recall names NTN since 2007.
Adverse event reports per year · NTN
42in 2025
MAUDE reports naming product code NTN, 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 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 47 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113679: Lucea Led Surgical Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113679
Report an extraction error
Are you the manufacturer?
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