Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Owen Mumford USA, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
267 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013362 | AUTOJECT 2 | Owen Mumford USA, Inc. | 2001-11-13 | 34 | 0 |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | Owen Mumford USA, Inc. | 1999-11-10 | 33 | 0 |
| K983994 | UNIFINE | Owen Mumford USA, Inc. | 1999-01-08 | 60 | 0 |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | Owen Mumford USA, Inc. | 1998-12-21 | 42 | 1 |
| K982275 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | 1998-12-04 | 158 | 0 |
| K983045 | AMIELLE | Owen Mumford USA, Inc. | 1998-11-25 | 85 | 0 |
| K973899 | UNIFINE PENTIPS | Owen Mumford USA, Inc. | 1997-12-04 | 51 | 0 |
| K971443 | RAPPORT V.T.D. | Owen Mumford USA, Inc. | 1997-09-26 | 158 | 0 |
| K953735 | AUTOJECT MINI | Owen Mumford USA, Inc. | 1995-11-08 | 90 | 0 |
| K945660 | AUTOJECT 2 | Owen Mumford USA, Inc. | 1995-08-11 | 267 | 1 |
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