510(k) · Cleared
Recalled · Class II · 2023Hanaulux Blue 30 & 80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Med GmbH · FSY Light, Surgical, Ceiling Mounted
Cleared on Feb 1, 1996 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 1996
- Review
- 149 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK954169 Hanaulux Blue 30 & 80Heraeus Med GmbH · 1996
- Descendant · cites it directly · 2 of its ownK113679 Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK130513 Volista 400; Volista 600Maquet S.A.S. · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954169 | Hanaulux Blue 30 & 80 | Heraeus Med GmbH | 1996 | — |
| +1 | K113679 | Lucea Led Surgical Light System | Maquet S.A.S. | 2012 | 1 |
| +2 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
| +2 | K130513 | Volista 400; Volista 600 | Maquet S.A.S. | 2013 | 19 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 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 FSY? 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113679 | Lucea Led Surgical Light System | 2012 | 2 |
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-0770-2024 | 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?
- Of its descendants, K113679 (Maquet S.A.S., 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSY
7in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FSY
59in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FSY
11in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSY
286in 2025
MAUDE reports naming product code FSY, 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 | 3 | 29 | 0 | 70 |
| 2008 | 2 | — | 0 | 53 |
| 2009 | 2 | — | 4 | 40 |
| 2010 | 5 | 130 | 3 | 72 |
| 2011 | 0 | — | 4 | 70 |
| 2012 | 2 | — | 4 | 171 |
| 2013 | 3 | 118 | 1 | 137 |
| 2014 | 7 | 59 | 0 | 139 |
| 2015 | 0 | — | 228 | 175 |
| 2016 | 0 | — | 0 | 182 |
| 2017 | 0 | — | 0 | 162 |
| 2018 | 0 | — | 2 | 316 |
| 2019 | 0 | — | 4 | 444 |
| 2020 | 0 | — | 0 | 439 |
| 2021 | 0 | — | 0 | 380 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 11 | 663 |
| 2024 | 0 | — | 0 | 541 |
| 2025 | 0 | — | 0 | 286 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K954169 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954169: Hanaulux Blue 30 & 80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954169
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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