510(k) · Cleared
ClearedAmico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ajw Technology Consultants, Inc. · FSY Light, Surgical, Ceiling Mounted
Cleared on Oct 30, 2013 as substantially equivalent to K093009 (Dr. Mach GmbH & Co. KG, 2010) and 1 other predicate after a 127-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Oct 30, 2013
- Review
- 127 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K965130 (1997). 10 ancestors in all, the oldest K904965 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 4 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 3 generations backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- 2 generations backK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- 1 generation backK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
- This deviceK131893 Amico CE Series Surgical Lights, Mira Led Series Minor Surgical LightsAjw Technology Consultants, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −4 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −3 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| −2 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| −1 | K093009 | Mach Led SC | Dr. Mach GmbH & Co. KG | 2010 | — |
| 0 (this device) | K131893 | Amico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights | Ajw Technology Consultants, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K093009 | Mach Led SCSummary page 3…dle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. Predicate Device: K093009 Mach LED SC K0930 10 Mach LED MC Substantial Equivalence: The Amico Clinic… | 2010 |
| * | K093010 | Mach Led MCSummary page 3…ed field as per the user's requirement. Predicate Device: K093009 Mach LED SC K0930 10 Mach LED MC Substantial Equivalence: The Amico Clinical Solutions Corp. - iCE LED Series and Amico Lights Corp. - Mira LED Serie… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K093009.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 intended use of the Amico ICE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.
The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during Minor surgery procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131893: Amico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131893
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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