510(k) · Cleared
Recalled · Class II · 2023Hanaulux Blue 80 Hospital
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Med GmbH · FSS Light, Surgical, Floor Standing
Cleared on Apr 16, 1997 after a 69-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 16, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- FSS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK970886 Hanaulux Blue 80 HospitalHeraeus Med GmbH · 1997
- 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) | K970886 | Hanaulux Blue 80 Hospital | Heraeus Med GmbH | 1997 | — |
| +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), 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 FSS? 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 |
|---|---|---|---|
| * | — | HANAULUX “City” series Named without a submission number | |
| * | — | Hanaulux 2000 Named without a submission number | |
| * | — | Hanaulux® blue 80 Stand Named without a submission number |
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 FSS devicesFSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FSS
Too few FSS 510(k)s in any year since 2007 to give a median.
Recalls per year · FSS
No recall names FSS since 2007.
Adverse event reports per year · FSS
3in 2025
MAUDE reports naming product code FSS, 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 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970886: Hanaulux Blue 80 Hospital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970886
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