Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pennine Medical , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
171 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854443 | O'NEIL URINARY CATHETER INTRODUCER | Pennine Medical , Ltd. | 1986-01-08 | 64 | 0 |
| K852859 | PENNINE CONNECTING TUBING | Pennine Medical , Ltd. | 1985-07-30 | 25 | 0 |
| K852081 | PENNINE OXYGEN LINK TUBING | Pennine Medical , Ltd. | 1985-06-14 | 32 | 0 |
| K844874 | PENNINE LINK YANKAUERS | Pennine Medical , Ltd. | 1985-06-06 | 171 | 0 |
| K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, | Pennine Medical , Ltd. | 1985-06-05 | 170 | 0 |
| K852079 | PENNINE DERBY YANKAUER | Pennine Medical , Ltd. | 1985-06-03 | 21 | 0 |
| K852080 | PENNINE SUCTION CATHETERS | Pennine Medical , Ltd. | 1985-06-03 | 21 | 0 |
| K844873 | PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 | Pennine Medical , Ltd. | 1985-02-21 | 66 | 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