Pennine Medical , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Pennine Medical , Ltd.” (first 1985, latest 1986), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Pennine Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854443 | O'NEIL URINARY CATHETER INTRODUCER | KOD | 1986-01-08 | 64 |
| K852859 | PENNINE CONNECTING TUBING | — | 1985-07-30 | 25 |
| K852081 | PENNINE OXYGEN LINK TUBING | BYX | 1985-06-14 | 32 |
| K844874 | PENNINE LINK YANKAUERS | GEA | 1985-06-06 | 171 |
| K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, | GBX | 1985-06-05 | 170 |
| K852080 | PENNINE SUCTION CATHETERS | BSY | 1985-06-03 | 21 |
| K852079 | PENNINE DERBY YANKAUER | BSY | 1985-06-03 | 21 |
| K844873 | PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 | CAE | 1985-02-21 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Pennine Medical , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pennine Medical , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Pennine Medical , Ltd.” (first 1985, latest 1986), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pennine Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pennine Medical , Ltd. is 48 days.
Which FDA product codes appear under Pennine Medical , Ltd.?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 2); BYX (Tubing, Pressure And Accessories, 1); CAE (Airway, Oropharyngeal, Anesthesiology, 1).
Next steps
- See all 8 Pennine Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BSY, Pennine Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.