# Owen Mumford, Ltd.

- Location (FDA's records): Woodstock, GB
- FDA decisions: 13 (2000–2023): 13 510(k) clearances
- Product codes: FMK (5), FMI (3), KZH (2), FMF (1), JKA (1), QRL (1)
- 510(k) review time since 2016: median 119 days, against 93 for FDA's reviews in the same codes and years (3 of 10 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medipurpose Pte., Ltd.: 3 (https://510kreport.com/company/medipurpose)
- Owen Mumford USA, Inc.: 2 (https://510kreport.com/company/owen-mumford-usa)
- Palco Laboratories, Inc.: 1 (https://510kreport.com/company/palco-laboratories)
- SteriLance Medical (Suzhou), Inc.: 1 (https://510kreport.com/company/sterilance-medical-suzhou)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Becton Dickinson Vacutainer Systems: 1 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)
- Roche Diabetes Care, Inc.: 1 (https://510kreport.com/company/roche-diabetes-care)

## Firms that cite its devices most
- Shl Medical, USA: 1 (https://510kreport.com/company/shl-medical-usa)
- Medical House (Asi) Limited: 1 (https://510kreport.com/company/medical-house-asi)

## Its most-cited devices
- K000482: Modification to Autoject Mini (2000), cited by 2
- K221126: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets (2022), cited by 1
- K173881: Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (2018), cited by 1
- K152339: Unifine Pentips/ Unifine Pentips Plus (2016), cited by 1

## Recent decisions
- K223854: Unistik® ShieldLock, Unistik VacuFlip (Jun 30, 2023)
- K231124: Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) (Jun 27, 2023)
- 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 (Nov 3, 2022)
- K222303: Unistik® Pro (Oct 25, 2022)
- K221613: Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (Oct 3, 2022)
- K222111: Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G (Sep 7, 2022)
- K221126: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets (Aug 12, 2022)
- K210399: Unifine SafeControl (Sep 17, 2021)

Source page: https://510kreport.com/company/owen-mumford