# Carilex Medical, Inc.

- Location (FDA's records): Taoyuan City, TW
- FDA decisions: 4 (2016–2024): 4 510(k) clearances
- Product codes: OMP (4)
- 510(k) review time since 2016: median 276 days, against 198 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 5 (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
- Suzric Enterprise Co., Ltd.: 2 (https://510kreport.com/company/suzric-enterprise)
- Cardinalhealth: 1 (https://510kreport.com/company/cardinalhealth)
- Medica-Rents Co., Ltd.: 1 (https://510kreport.com/company/medica-rents)

## Firms that cite its devices most
- 4l Health Co., Ltd.: 1 (https://510kreport.com/company/4l-health)

## Its most-cited devices
- K173407: VT - 100, VT - 200 (2018), cited by 1
- K172725: VT Dressing Kits (2018), cited by 1

## Recent decisions
- K231646: Carilex VT¿200-i NX (Apr 17, 2024)
- K173407: VT - 100, VT - 200 (Aug 9, 2018)
- K172725: VT Dressing Kits (Jun 8, 2018)
- K161410: VT·One, VT·One 60days (Oct 13, 2016)

Source page: https://510kreport.com/company/carilex-medical