Warne Surgical Products, Ltd.: FDA clearances and approvals
Warne Surgical Products, Ltd. has 15 FDA 510(k) clearances (first 1984, latest 1985), across 8 product codes in 4 review panels. Median 510(k) review time: 34 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 4 | 4 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 2 | 2 |
| BTC | Bag, Reservoir | 2 | 2 |
| BYZ | Trap, Sterile Specimen | 1 | 1 |
| DRM | Compressor, Cardiac, External | 1 | 1 |
| KDN | System, Perfusion, Kidney | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Review panels
Most recent Warne Surgical Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC | FAP | 1985-05-17 | 85 |
| K850694 | WSP CODE 4310 STRESSCATH | FAP | 1985-05-17 | 85 |
| K850695 | WSP CODE 4301 DIOMASTER THERAPEUTIC | FAP | 1985-05-16 | 84 |
| K850693 | WSP CODE 4315 PADTEST | FAP | 1985-05-10 | 78 |
| K841511 | HAEMATURIA CATHETERS | KOD | 1984-07-12 | 92 |
| K840687 | KIDNEY TRANSPLANT CATHETER | KDN | 1984-06-07 | 113 |
| K841412 | ROLLED NECK W/TAP | BTC | 1984-04-18 | 13 |
| K841411 | ROLLED NECK W/PLUG | BTC | 1984-04-18 | 13 |
| K841410 | BUSH NECK W/TAP | DRM | 1984-04-18 | 13 |
| K841409 | BUSH NECK W/PLUG | BYZ | 1984-04-18 | 13 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Warne Surgical Products, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Warne Surgical Products, Ltd. have?
Warne Surgical Products, Ltd. has 15 FDA 510(k) clearances (first 1984, latest 1985), across 8 product codes in 4 review panels.
How long does FDA take to clear Warne Surgical Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Warne Surgical Products, Ltd.'s cleared 510(k)s is 34 days.
What devices does Warne Surgical Products, Ltd. make?
Its most frequent FDA product codes are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 4); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 3); BSJ (Mask, Gas, Anesthetic, 2).
Has Warne Surgical Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Warne Surgical Products, Ltd. Related entities may recall under other names.
Next steps
- See all 15 Warne Surgical Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Warne Surgical Products, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.