Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Poly Medicure Limited — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
232 daysmedian FDA review time
434 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64 | Poly Medicure Limited | 2026-04-01 | 233 | 0 |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | 2025-11-05 | 72 | 0 |
| K232234 | Nouvo Safety Set | Poly Medicure Limited | 2024-03-15 | 232 | 0 |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin S | Poly Medicure Limited | 2023-09-21 | 129 | 0 |
| K230616 | Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited | 2023-05-05 | 60 | 0 |
| K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | 2023-04-12 | 434 | 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