# K840372: Flexible Illuminator 15

- Pathway: 510(k) (Traditional)
- Applicant: Suncoast Medical Manufacturers, Inc.
- Decided: Apr 24, 1984 after 88 days
- Product code: FTF (Illuminator, Non-Remote)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041621: Liteport LP100 Surgical Illuminator (2004), 2 descendants of its own
- K253531: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (2026), 1 descendant of its own
- K071180: Scintillant Surgical Light, Model 2644-01-0001 (2007), 1 descendant of its own
- K260982: Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) (2026), 0 descendants of its own
- K133425: Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K840372
Methodology: https://510kreport.com/methodology