# Gri-Alleset, Inc.

- Location (FDA's records): Flowery Branch, GA
- FDA decisions: 4 (2021–2024): 4 510(k) clearances
- Product codes: FMK (2), FYC (1), FXX (1)
- 510(k) review time since 2016: median 141 days, against 100 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (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
- Gri Medical & Electronic Technology Co., Ltd.: 2 (https://510kreport.com/company/gri-medical-electronic-technology)
- International Technidyne Corp.: 2 (https://510kreport.com/company/international-technidyne)

## Its most-cited devices
- K220917: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (2022), cited by 1

## Recent decisions
- K242664: gentleheel® Adult Incision Device (Nov 5, 2024)
- K220917: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (May 18, 2022)
- K210860: Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 (Apr 7, 2022)
- K210131: ComfortGuard Surgical Isolation Gown (Aug 26, 2021)

Source page: https://510kreport.com/company/gri-alleset