Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Equashield Medical , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
279 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221513 | Equashield Closed System Transfer Device | Equashield Medical , Ltd. | 2023-02-17 | 268 | 0 |
| K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical , Ltd. | 2017-07-03 | 117 | 0 |
| K150219 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical , Ltd. | 2015-11-05 | 279 | 0 |
| K132899 | EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) | Equashield Medical , Ltd. | 2014-05-13 | 239 | 0 |
| K101940 | EQUASHIELD SYSTEM PROTECTIVE PLUS | Equashield Medical , Ltd. | 2010-11-19 | 130 | 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