# Simplivia Healthcare, Ltd.

- Location (FDA's records): Kiryat Shmona, IL
- FDA decisions: 6 (2020–2025): 6 510(k) clearances
- Product codes: ONB (6)
- 510(k) review time since 2016: median 144 days, against 194 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teva Medical Ltd., Migada Plant: 2 (https://510kreport.com/company/teva-medical-migada-plant)
- Migada Plant: 1 (https://510kreport.com/company/migada-plant)

## Its most-cited devices
- K192866: Chemfort CSTD (2020), cited by 3

## Recent decisions
- K253033: Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (Oct 21, 2025)
- K251411: Chemfort Female Luer Lock Adaptor (Aug 5, 2025)
- K231286: Chemfort® Catheter Adaptor (Aug 2, 2023)
- K210707: OnGuard2 Chemfort Closed Administration (CADM) (Sep 23, 2021)
- K201142: TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set (Feb 25, 2021)
- K192866: Chemfort CSTD (May 7, 2020)

Source page: https://510kreport.com/company/simplivia-healthcare