Owen Mumford USA, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Owen Mumford USA, Inc.” (first 1995, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | 4 | 4 |
| FMF | Syringe, Piston | 2 | 2 |
| LKY | Device, External Penile Rigidity | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| KXP | Stent, Vaginal | 1 | 1 |
Review panels
Most recent Owen Mumford USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013362 | AUTOJECT 2 | KZH | 2001-11-13 | 34 |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | KZH | 1999-11-10 | 33 |
| K983994 | UNIFINE | FMF | 1999-01-08 | 60 |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | FMF | 1998-12-21 | 42 |
| K982275 | RAPPORT V.T.D. | LKY | 1998-12-04 | 158 |
| K983045 | AMIELLE | KXP | 1998-11-25 | 85 |
| K973899 | UNIFINE PENTIPS | FMI | 1997-12-04 | 51 |
| K971443 | RAPPORT V.T.D. | LKY | 1997-09-26 | 158 |
| K953735 | AUTOJECT MINI | KZH | 1995-11-08 | 90 |
| K945660 | AUTOJECT 2 | KZH | 1995-08-11 | 267 |
Recalls
7 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2021-05-26.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Owen Mumford, Ltd. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Owen Mumford USA, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Owen Mumford USA, Inc.” (first 1995, latest 2001), across 5 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 Owen Mumford USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Owen Mumford USA, Inc. is 72 days.
Which FDA product codes appear under Owen Mumford USA, Inc.?
The most frequent FDA product codes under this applicant name are KZH (Introducer, Syringe Needle, 4); FMF (Syringe, Piston, 2); LKY (Device, External Penile Rigidity, 2).
Next steps
- See all 10 Owen Mumford USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KZH, Owen Mumford USA, Inc.'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.