Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Medication Systems, 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) |
|---|---|---|---|---|---|
| K945797 | STERILE EMPTY PCA SYRINGE | Intl. Medication Systems, Ltd. | 1995-05-19 | 172 | 0 |
| K870414 | QUIK-BRUSH | Intl. Medication Systems, Ltd. | 1987-06-11 | 128 | 0 |
| K860468 | UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE | Intl. Medication Systems, Ltd. | 1986-03-18 | 40 | 0 |
| K854752 | THE CALIFORNIA SPLINT | Intl. Medication Systems, Ltd. | 1985-12-17 | 21 | 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