# K040735: Alm X'ten (X10) Surgical Light System

- Pathway: 510(k) (Special)
- Applicant: Alm S.A.
- Decided: May 21, 2004 after 60 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904965 (1991). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904965: Shampaine 1000 Series Angenieux AX-14 Duo,AX-4, Smith & Nephew Equipment Group (1991) Summary page 1.

## Most influential descendants
- K070442: Powerled Surgical Light System (2007), 14 descendants of its own
- K072072: Harmony Led-1 Surgical Lighting System (2007), 10 descendants of its own
- K093009: Mach Led SC (2010), 4 descendants of its own
- K113679: Lucea Led Surgical Light System (2012), 2 descendants of its own
- K132307: Vida Led Surgical Lighting System (2013), 1 descendant of its own

## Recalls of this device
- Nov 8, 2023 · Class II · Z-0766-2024: A potential for a light system to fall in the operating room.
- Nov 16, 2017 · Class II · Z-1927-2018: Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms 
- May 29, 2015 · Class II · Z-1990-2015: Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field
- Oct 7, 2009 · Not classified · Z-0186-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j
- Oct 7, 2009 · Not classified · Z-0188-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j
- Oct 7, 2009 · Not classified · Z-0187-2010: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front j

## Indications for use
ALM X'Ten TM (X10) Surgical Light Systems with Energix TM Power Supply are intended to be used to provide visible illumination of the surgical area or the patient. An optional "LEDinside" feature is available and produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examinations. The Energix TM Power Supply is intended for use with surgical light systems.

Source page: https://510kreport.com/device/K040735
Methodology: https://510kreport.com/methodology