Owen Mumford Limited
Chipping Norton Oxfordshire, GB
Owen Mumford Limited appears in FDA device records in Chipping Norton Oxfordshire, GB. FDA records list 13 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Owen Mumford Limited between 2000 and 2023. The busiest year on record is 2022, with 5. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | JKA | Substantially Equivalent | |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | FMK | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K222303 | Unistik® Pro | FMK | Substantially Equivalent | |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | QRL | Substantially Equivalent | |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | FMK | Substantially Equivalent | |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | FMK | Substantially Equivalent | |
| K210399 | Unifine SafeControl | FMI | Substantially Equivalent | |
| K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | FMI | Substantially Equivalent | |
| K152339 | Unifine Pentips/ Unifine Pentips Plus | FMI | Substantially Equivalent | |
| K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | KZH | Substantially Equivalent | |
| K011951 | EZ SYRINGE | FMF | Substantially Equivalent | |
| K000482 | MODIFICATION TO AUTOJECT MINI | KZH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021764 | 3000191104 | OWEN MUMFORD, LTD. | BROOK HILL, WOODSTOCK, OXFORDSHIRE 0X20ITU GB | 2026 | |
| 3003348846 | 3003348846 | Owen Mumford Limited | Primsdown Industrial Estate, Chipping Norton Oxfordshire OX7 5XP GB | 2026 | and 1 more, listed in full below |
| 3038110468 | 3038110468 | Owen Mumford Limited | De Havilland Way,, Witney Oxfordshire OX29 0YG GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LKYDevice, External Penile Rigidity
- KCMDropper, Ent
- GXBEsthesiometer
- IONExerciser, Non-Measuring
- KZHIntroducer, Syringe Needle
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- FMINeedle, Hypodermic, Single Lumen
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- KXPStent, Vaginal
- FMFSyringe, Piston
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain