Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Chalice Medical , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | 2023-11-01 | 169 | 0 |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | Chalice Medical , Ltd. | 2020-09-18 | 93 | 0 |
| K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | Chalice Medical , Ltd. | 2020-02-28 | 295 | 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