Data / Medical devices / United Kingdom / Owen Mumford Limited
Owen Mumford Limited: FDA-registered device maker in Chipping Norton Oxfordshire, United Kingdom, 11 510(k) clearances
Owen Mumford Limited is registered with the FDA (registration 3003348846) in Chipping Norton Oxfordshire, United Kingdom. It lists 11 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 3, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003348846
- Address
- Primsdown Industrial Estate Worcester Road, Chipping Norton Oxfordshire, United Kingdom, OX7 5XP
- Owner or operator
- OWEN MUMFORD LTD. (8021764)
- Roles
- Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- December 2, 1992
- Registered through
- 2026
- Brand names listed
- AUTODROP, AUTOJECT 2 (FIXED NEEDLE), AUTOJECT 2 (NON-FIXED NEEDLE), AUTOSQUEEZE, Amielle, Autoject 2, Autoject II, Autolet and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, External Penile Rigidity | LKY | 2 | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dropper, Ent | KCM | 1 | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Esthesiometer | GXB | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stent, Vaginal | KXP | 2 | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2022 | K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | QRL | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| July 11, 2018 | K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | FMI | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| June 24, 2016 | K152339 | Unifine Pentips/ Unifine Pentips Plus | FMI | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| October 15, 2012 | K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | KZH | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| November 13, 2001 | K013362 | AUTOJECT 2 | KZH | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| November 10, 1999 | K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | KZH | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| December 21, 1998 | K983974 | OWEN MUMFORD 3ML AUTOPEN | FMF | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| November 25, 1998 | K983045 | AMIELLE | KXP | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| December 4, 1997 | K973899 | UNIFINE PENTIPS | FMI | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| August 11, 1995 | K945660 | AUTOJECT 2 | KZH | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| February 16, 1990 | K895890 | AUTOPEN | FMF | Substantially Equivalent | Ulster Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, External Penile Rigidity
- All makers of Dropper, Ent
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
Updated October 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.