FDA applicant
Care Essentials Pty, Ltd.
FDA records 4 decisions for Care Essentials Pty, Ltd. (North Geelong, AU) from 2014 to 2024: 4 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and FRG (Wrap, Sterilization). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Care Essentials Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2020
Class I Class II/III not classified
Planning a device like Care Essentials Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report