Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Care Essentials Pty, Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024-02-21 | 187 | 0 |
| K213907 | CareGUARD Sterilization Wrap | Care Essentials Pty, Ltd. | 2022-03-14 | 90 | 0 |
| K181671 | Cocoon Convective Warming System | Care Essentials Pty, Ltd. | 2019-05-02 | 311 | 0 |
| K140635 | COCOON CONVECTIVE WARMING SYSTEM | Care Essentials Pty, Ltd. | 2014-07-25 | 135 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda