FDA applicant

Flexicare

Mid Glam, GB1 decision2014–20140 recalls

FDA records 1 decision for Flexicare (Mid Glam, GB) in 2014: 1 510(k) clearance. All are in product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 1 predicate, 0 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 Flexicare’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Flexicare by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Flexicare’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) Report

Other applicant names beginning “Flexicare”

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

Flexicare Medical Limited. 16

Flexicare

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Flexicare”