Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Warne Surgical Products, Ltd. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
92 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850694 | WSP CODE 4310 STRESSCATH | Warne Surgical Products, Ltd. | 1985-05-17 | 85 | 0 |
| K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC | Warne Surgical Products, Ltd. | 1985-05-17 | 85 | 0 |
| K850695 | WSP CODE 4301 DIOMASTER THERAPEUTIC | Warne Surgical Products, Ltd. | 1985-05-16 | 84 | 0 |
| K850693 | WSP CODE 4315 PADTEST | Warne Surgical Products, Ltd. | 1985-05-10 | 78 | 0 |
| K841511 | HAEMATURIA CATHETERS | Warne Surgical Products, Ltd. | 1984-07-12 | 92 | 0 |
| K840687 | KIDNEY TRANSPLANT CATHETER | Warne Surgical Products, Ltd. | 1984-06-07 | 113 | 0 |
| K841410 | BUSH NECK W/TAP | Warne Surgical Products, Ltd. | 1984-04-18 | 13 | 0 |
| K841409 | BUSH NECK W/PLUG | Warne Surgical Products, Ltd. | 1984-04-18 | 13 | 0 |
| K841411 | ROLLED NECK W/PLUG | Warne Surgical Products, Ltd. | 1984-04-18 | 13 | 0 |
| K841412 | ROLLED NECK W/TAP | Warne Surgical Products, Ltd. | 1984-04-18 | 13 | 0 |
| K840704 | SECURE W/35MM DIAM, SHEATH/ADHESIVE | Warne Surgical Products, Ltd. | 1984-03-22 | 34 | 0 |
| K840703 | SECURE W/30MM DIAM, SHEATH & ADHESIVE | Warne Surgical Products, Ltd. | 1984-03-22 | 34 | 0 |
| K840702 | SECURE W/25MM DIAM. SHEATH & ADHESIVE | Warne Surgical Products, Ltd. | 1984-03-22 | 34 | 0 |
| K834536 | CRYSTALCONE FACE MASK-MED-W/HOOKRING | Warne Surgical Products, Ltd. | 1984-01-25 | 34 | 0 |
| K834454 | PAEDIATRIC FACE MASK 1-3 W/WO RING | Warne Surgical Products, Ltd. | 1984-01-18 | 30 | 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