# Gel-E, Inc.

- Location (FDA's records): College Park, MD
- FDA decisions: 3 (2018–2019): 3 510(k) clearances
- Product codes: QSY (3)
- 510(k) review time since 2016: median 154 days, against 336 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hem Con Medical Technologies, Inc.: 2 (https://510kreport.com/company/hem-con-medical-technologies)

## Firms that cite its devices most
- Cresilon, Inc.: 1 (https://510kreport.com/company/cresilon)

## Its most-cited devices
- K182811: gel-e Flex+ (2019), cited by 1
- K180152: gel-e Flex (2018), cited by 1

## Recent decisions
- K192667: gel-e Flex+ gel OTC (Oct 25, 2019)
- K182811: gel-e Flex+ (Aug 29, 2019)
- K180152: gel-e Flex (Jun 22, 2018)

Source page: https://510kreport.com/company/gel-e