# Chalice Medical, Ltd.

- Location (FDA's records): Worksop, GB
- FDA decisions: 3 (2020–2023): 3 510(k) clearances
- Product codes: DTZ (3)
- 510(k) review time since 2016: median 169 days, against 93 for FDA's reviews in the same codes and years (0 of 3 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
- Sorin Group Italia S.R.L.: 2 (https://510kreport.com/company/sorin-group-italia)
- Cobe Laboratories, Inc.: 1 (https://510kreport.com/company/cobe-laboratories)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)

## Its most-cited devices
- K201642: Paragon Adult Maxi PMP Oxygenator with Tubing Pack (2020), cited by 1

## Recent decisions
- K231414: CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (Nov 1, 2023)
- K201642: Paragon Adult Maxi PMP Oxygenator with Tubing Pack (Sep 18, 2020)
- K191246: Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) (Feb 28, 2020)

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