# K182811: gel-e Flex+

- Pathway: 510(k) (Traditional)
- Applicant: Gel-E, Inc.
- Decided: Aug 29, 2019 after 330 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896068 (1990). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO, Hem Con Medical Technologies, Inc. (2015) Summary page 5.

## Most influential descendants
- K192667: gel-e Flex+ gel OTC (2019), 0 descendants of its own

## Indications for use
gel-e Flex+ is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

Source page: https://510kreport.com/device/K182811
Methodology: https://510kreport.com/methodology