FDA applicant
Bedfont Scientific, Ltd.
FDA records 6 decisions for Bedfont Scientific, Ltd. (Maidstone, Kent, GB) from 2000 to 2021: 6 510(k) clearances. Most are in product codes CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase) and MXA (System, Test, Breath Nitric Oxide). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bedfont Scientific, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bedfont Scientific, 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 “Bedfont”
FDA records each applicant name separately; these may or may not be the same firm.