Data / Medical devices / United States / Owen Mumford Usa, Inc.
Owen Mumford Usa, Inc.: FDA-registered device maker in Marietta, GA, United States, 17 510(k) clearances
Owen Mumford Usa, Inc. is registered with the FDA (registration 1058602) in Marietta, GA, United States. It lists 13 device types. The FDA files 17 510(k) clearances under its listings, the newest dated October 30, 2024. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1058602
- FEI number
- 1000219614
- Address
- 1755 W Oak Commons Ct, Marietta, GA, United States, 30062
- Owner or operator
- OWEN MUMFORD LTD. (8021764)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- December 2, 1992
- Registered through
- 2026
- Brand names listed
- AUTODROP, AUTOJECT 2 (NON-FIXED NEEDLE), AUTOSQUEEZE, Amielle, Amielle Restore, Autoject 2, Autolet, Autolet Lite and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Components, Exercise | IOD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Device, External Penile Rigidity | LKY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dropper, Ent | KCM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Esthesiometer | GXB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stent, Vaginal | KXP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 30, 2024 | K242627 | Safety Lancet | FMK | Substantially Equivalent | Ningbo Medsun Medical Co., Ltd. | accessdata.fda.gov |
| 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 |
| November 19, 2021 | K212015 | BD Nano 2nd Gen Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 17, 2021 | K210399 | Unifine SafeControl | FMI | 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 |
| 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 26, 2021 | 88013 | Class II | Ongoing | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. | Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles. | accessdata.fda.gov |
| July 17, 2019 | 83465 | Class II | Ongoing | Autoject EI, REF AJ1310 | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107 | accessdata.fda.gov |
| November 6, 2017 | 78483 | Class II | Terminated | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. | Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal. | accessdata.fda.gov |
| December 11, 2014 | 70783 | Class II | Terminated | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin. | The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection. | accessdata.fda.gov |
| November 24, 2014 | 70665 | Class II | Terminated | Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor. | The syringe carrier is missing components: a damper and spring. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Introducer, Syringe Needle
- All makers of Esthesiometer
- All makers of Syringe, Piston
- All makers of Components, Exercise
Updated October 30, 2024. 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.