# K013242: Amsco Harmony Surgical Lighting and Media System

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Dec 13, 2001 after 76 days
- Product code: FTD (Lamp, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Amsco SQ240 Surgical Light: named in the summary without a submission number
- (no number) Hill-Rom BrightStar Surgical Light: named in the summary without a submission number
- (no number) Berchtold Chromophare D650 Surgical Light: named in the summary without a submission number

## Most influential descendants
- K072072: Harmony Led-1 Surgical Lighting System (2007), 10 descendants of its own
- K093009: Mach Led SC (2010), 4 descendants of its own
- K132307: Vida Led Surgical Lighting System (2013), 1 descendant of its own
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems (2010), 1 descendant of its own
- K140812: MI-750 Procedural/Minor Surgical Light (2014), 0 descendants of its own

## Recalls of this device
- Feb 18, 2011 · Not classified · Z-1886-2011: 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: Premature Bulb Failure
- Feb 23, 2010 · Not classified · Z-1218-2010: Premature Bulb Failure
- Feb 23, 2010 · Not classified · Z-1220-2010: Premature Bulb Failure

## Indications for use
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.

Source page: https://510kreport.com/device/K013242
Methodology: https://510kreport.com/methodology