Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Simplivia Healthcare , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
302 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | 2025-10-21 | 29 | 0 |
| K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. | 2025-08-05 | 90 | 0 |
| K231286 | Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. | 2023-08-02 | 90 | 0 |
| K210707 | OnGuard2 Chemfort Closed Administration (CADM) | Simplivia Healthcare , Ltd. | 2021-09-23 | 197 | 0 |
| K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with UL | Simplivia Healthcare , Ltd. | 2021-02-25 | 302 | 0 |
| K192866 | Chemfort CSTD | Simplivia Healthcare , Ltd. | 2020-05-07 | 213 | 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