Owen Mumford, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Owen Mumford, Ltd.” (first 2000, latest 2023), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 105 days. Since 2017 the median was 116 days, against 142 days for all cleared 510(k)s in the same product codes. 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 | 1 | 28 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 310 |
| 2017 | 0 | — |
| 2018 | 1 | 202 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 219 |
| 2022 | 5 | 105 |
| 2023 | 2 | 128 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Owen Mumford, Ltd. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 5 | 5 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| KZH | Introducer, Syringe Needle | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 | 1 |
Review panels
Most recent Owen Mumford, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | JKA | 2023-06-30 | 189 |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | FMK | 2023-06-27 | 68 |
| K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler | FMK | 2022-11-03 | 105 |
| K222303 | Unistik® Pro | FMK | 2022-10-25 | 85 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | QRL | 2022-10-03 | 122 |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | FMK | 2022-09-07 | 51 |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | FMK | 2022-08-12 | 116 |
| K210399 | Unifine SafeControl | FMI | 2021-09-17 | 219 |
| K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | FMI | 2018-07-11 | 202 |
| K152339 | Unifine Pentips/ Unifine Pentips Plus | FMI | 2016-06-24 | 310 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Owen Mumford, 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.
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 USA, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Owen Mumford, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Owen Mumford, Ltd.” (first 2000, latest 2023), across 6 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, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Owen Mumford, Ltd. is 105 days. Since 2017: 116 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Owen Mumford, Ltd.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 5); FMI (Needle, Hypodermic, Single Lumen, 3); KZH (Introducer, Syringe Needle, 2).
Next steps
- See all 13 Owen Mumford, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Owen Mumford, 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.