FDA applicant
Owen Mumford, Ltd.
FDA records 13 decisions for Owen Mumford, Ltd. (Woodstock, GB) from 2000 to 2023: 13 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Owen Mumford, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Owen Mumford, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Owen”
FDA records each applicant name separately; these may or may not be the same firm.