510(k) Report

FDA applicant

Bedfont Scientific, Ltd.

Maidstone, Kent, GB6 decisions2000–20210 recalls

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, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Bedfont Scientific, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2008: 12010: 12019: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bedfont Scientific, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Bedfont”

FDA records each applicant name separately; these may or may not be the same firm.