510(k) · Cleared
Recalled · 2011Amsco Harmony Surgical Lighting and Media System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FTD Lamp, Surgical
Cleared on Dec 13, 2001 after a 76-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 13, 2001
- Review
- 76 days
- Class
- Class II
- Product code
- FTD
- Recalls
- 4
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK013242 Amsco Harmony Surgical Lighting and Media SystemSTERIS Corporation · 2001
- Descendant · cites it directly · 10 of its ownK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK093009 Mach Led SCDr. Mach GmbH & Co. KG · 2010
- Descendant · 3 generations on · 1 of its ownK132307 Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK100388 21ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK140812 MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072072Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · cites it directly10descendants
- K093009Mach Led SCDr. Mach GmbH & Co. KG · 2010 · 2 generations on4descendants
- K132307Vida Led Surgical Lighting SystemConvida Healthcare & Systems Corporation · 2013 · 3 generations on1descendant
- K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010 · 2 generations on1descendant
- K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013242 | Amsco Harmony Surgical Lighting and Media System | STERIS Corporation | 2001 | — |
| +1 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| +2 | K093009 | Mach Led SC | Dr. Mach GmbH & Co. KG | 2010 | — |
| +3 | K132307 | Vida Led Surgical Lighting System | Convida Healthcare & Systems Corporation | 2013 | — |
| +2 | K100388 | 21ST Century Centurion Exceled and System Two Led Lighting Systems | Medical Illumination International, Inc. | 2010 | — |
| +3 | K140812 | MI-750 Procedural/Minor Surgical Light | Medical Illumination International, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 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 FTD? 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 |
|---|---|---|---|
| * | — | Amsco SQ240 Surgical Light Named without a submission number | |
| * | — | Hill-Rom BrightStar Surgical Light Named without a submission number | |
| * | — | Berchtold Chromophare D650 Surgical Light Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072072 | Harmony Led-1 Surgical Lighting System | 2007 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2011 | Not classified | Z-1886-2011 | Other | The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter |
| Feb 23, 2010 | Not classified | Z-1219-2010 | Device Design | Premature Bulb Failure |
| Feb 23, 2010 | Not classified | Z-1218-2010 | Device Design | Premature Bulb Failure |
| Feb 23, 2010 | Not classified | Z-1220-2010 | Device Design | Premature Bulb Failure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072072 (STERIS Corporation, 2007) has gone furthest, with 10 descendants of its own.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, 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 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff.
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/K013242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013242: Amsco Harmony Surgical Lighting and Media System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013242
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026