510(k) · Cleared
Cleared21ST Century Centurion Exceled and System Two Led Lighting Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Illumination International, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Jun 22, 2010 as substantially equivalent to K083066 (Berchtold Holding GmbH, 2008) and 4 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Jun 22, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K965130 (1997). 12 ancestors in all, the oldest K904965 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 3 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 2 generations backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- 1 generation backK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- This deviceK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −3 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −2 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| −1 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| 0 (this device) | K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | Medical Illumination International, Inc. | 2010 | — |
| +1 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FST device
- #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K083066 | Chromophare E 778 and E 558Summary page 1…gical Light Classification Number: 21 CFR 878.4580 Product Code: FSY Predicate Devices: * Berchtold Chromophare E558 and E778 510 (k): K083066 dated October 30, 2008 Product Code: FSY * Maquet Power-LED 500 Surgical Light 5 10(k): K070442 dated March… | 2008 |
| * | K070442 | Powerled Surgical Light SystemSummary page 1…Berchtold Chromophare E558 and E778 510 (k): K083066 dated October 30, 2008 Product Code: FSY * Maquet Power-LED 500 Surgical Light 5 10(k): K070442 dated March 16, 2007 Product Code: FSY * Skytron Aurora LED Series Surgical Light 510 (k): K071698 dated July… | 2007 |
| * | K071698 | Aurora Led Series Surgical LightsSummary page 1…quet Power-LED 500 Surgical Light 5 10(k): K070442 dated March 16, 2007 Product Code: FSY * Skytron Aurora LED Series Surgical Light 510 (k): K071698 dated July 6, 2007 Product Code: FSY * Steris Harmony LED-I Surgical Lighting System 510 (k): K072072 dated O… | 2007 |
| * | K072072 | Harmony Led-1 Surgical Lighting SystemSummary page 1…urora LED Series Surgical Light 510 (k): K071698 dated July 6, 2007 Product Code: FSY * Steris Harmony LED-I Surgical Lighting System 510 (k): K072072 dated October 5, 2007 Product Code FSY * Trumpf Kreuzer Medizin iLED Surgical Lighting System 5 10 (k): K0613… | 2007 |
| * | K061317 | ILEDSummary page 1…gical Lighting System 510 (k): K072072 dated October 5, 2007 Product Code FSY * Trumpf Kreuzer Medizin iLED Surgical Lighting System 5 10 (k): K061317 dated June 22, 2006 Product Code FSY 547 LIBRARY ST. * SAN FERNANDO. CALIFORNIA 91340 * PHONE 818-838-3025 *FAX 818-83… | 2006 |
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 |
|---|---|---|---|
| K140812 | MI-750 Procedural/Minor Surgical Light | 2014 | 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 13 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 6 of the 12 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.
- 2 other devices also cite its predicate K083066.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FST
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FST
59in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FST
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FST
27in 2025
MAUDE reports naming product code FST, 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 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 100 | 0 | 4 |
| 2010 | 5 | 90 | 0 | 3 |
| 2011 | 0 | — | 10 | 7 |
| 2012 | 3 | 59 | 0 | 14 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 1 | 13 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The System Two LED surgical Lighting System is an AC powered device which provides a focusable
field of illumination for general examination and surgery.
It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
D1 = small minor surgical light / satellite
D2 = large minor surgical light
D3 = major surgical light
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100388
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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