# K072072: Harmony Led-1 Surgical Lighting System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Oct 5, 2007 after 67 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965130 (1997). 7 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070442: Powerled Surgical Light System, Maquet S.A. (2007) Summary page 1.
- K061317: ILED, Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (2006) Summary page 1.
- K013242: Amsco Harmony Surgical Lighting and Media System, STERIS Corporation (2001) Summary page 1.

## Most influential descendants
- 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
- K140930: Vida Led Surgical Lighting System, V Series (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

## Indications for use
The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

Source page: https://510kreport.com/device/K072072
Methodology: https://510kreport.com/methodology