Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Owen Mumford, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
219 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford, Ltd. | 2023-06-30 | 189 | 0 |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal ( | Owen Mumford, Ltd. | 2023-06-27 | 68 | 0 |
| K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety La | Owen Mumford, Ltd. | 2022-11-03 | 105 | 0 |
| K222303 | Unistik® Pro | Owen Mumford, Ltd. | 2022-10-25 | 85 | 0 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet L | Owen Mumford, Ltd. | 2022-10-03 | 122 | 0 |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G | Owen Mumford, Ltd. | 2022-09-07 | 51 | 0 |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Va | Owen Mumford, Ltd. | 2022-08-12 | 116 | 0 |
| K210399 | Unifine SafeControl | Owen Mumford, Ltd. | 2021-09-17 | 219 | 0 |
| K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | Owen Mumford, Ltd. | 2018-07-11 | 202 | 0 |
| K152339 | Unifine Pentips/ Unifine Pentips Plus | Owen Mumford, Ltd. | 2016-06-24 | 310 | 0 |
| K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | Owen Mumford, Ltd. | 2012-10-15 | 28 | 0 |
| K011951 | EZ SYRINGE | Owen Mumford, Ltd. | 2001-08-02 | 42 | 0 |
| K000482 | MODIFICATION TO AUTOJECT MINI | Owen Mumford, Ltd. | 2000-03-06 | 21 | 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