510(k) · Cleared
Recalled · Class II · 2024Aurora Led Series Surgical Lights
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skytron, Div. the Kmw Group, Inc. · FSY Light, Surgical, Ceiling Mounted
Cleared on Jul 6, 2007 as substantially equivalent to K002463 (Skytron, Div. the Kmw Group, Inc., 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 6, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002463 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002463 StellarSkytron, Div. the Kmw Group, Inc. · 2000
- This deviceK071698 Aurora Led Series Surgical LightsSkytron, Div. the Kmw Group, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK083323 Nuvo Verde Led Lighting SystemNuvo, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010 · cites it directly1descendant
- K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014 · 2 generations on0descendants
- K083323Nuvo Verde Led Lighting SystemNuvo, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002463 | Stellar | Skytron, Div. the Kmw Group, Inc. | 2000 | — |
| 0 (this device) | K071698 | Aurora Led Series Surgical Lights | Skytron, Div. the Kmw Group, Inc. | 2007 | — |
| +1 | K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | Medical Illumination International, Inc. | 2010 | — |
| +2 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
| +1 | K083323 | Nuvo Verde Led Lighting System | Nuvo, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K002463 | StellarSummary page 1…Centers and Doctor's offices PREDICATE DEVICE: TRADE NAME: STELLAR 510 (k): K002463 PRODUCT CODE: FSY INDICATIONS FOR USE The SKYTRON… | 2000 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Jul 9, 2024 | Class II | Z-2618-2024 | Process control | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. |
| Jul 9, 2024 | Class II | Z-2620-2024 | Process control | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. |
| Jul 9, 2024 | Class II | Z-2621-2024 | Process control | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. |
| Jul 9, 2024 | Class II | Z-2619-2024 | Process control | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K100388 (Medical Illumination International, Inc., 2010) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The SKYTRON Aurora Series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071698: Aurora Led Series Surgical Lights.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071698
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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