Data / Medical devices / United Kingdom / Owen Mumford, Ltd.
Owen Mumford, Ltd.: FDA-registered device maker in Woodstock, Oxfordshire, United Kingdom, 14 510(k) clearances
Owen Mumford, Ltd. is registered with the FDA (registration 8021764) in Woodstock, Oxfordshire, United Kingdom. It lists 10 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8021764
- FEI number
- 3000191104
- Address
- Brook Hill, Woodstock, Oxfordshire, United Kingdom, 0X20ITU
- Owner or operator
- OWEN MUMFORD LTD. (8021764)
- Roles
- Complaint file establishment, 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 | Manufacturer | accessdata.fda.gov |
| Dropper, Ent | KCM | 1 | Manufacturer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment | accessdata.fda.gov |
| Stent, Vaginal | KXP | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 30, 2023 | K223854 | Unistik® ShieldLock, Unistik VacuFlip | JKA | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| November 3, 2022 | 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 | Owen Mumford, Ltd. | accessdata.fda.gov |
| October 25, 2022 | K222303 | Unistik® Pro | FMK | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| October 3, 2022 | K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | QRL | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| September 7, 2022 | K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | FMK | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| August 12, 2022 | 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 | Owen Mumford, Ltd. | accessdata.fda.gov |
| September 17, 2021 | K210399 | Unifine SafeControl | 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 |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Device, External Penile Rigidity
- All makers of Introducer, Syringe Needle
- All makers of Dropper, Ent
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated June 30, 2023. 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.