510(k) Report

FDA applicant

Clearwater Clinical Limited

Calgary, Alberta, CA1 decision2008–20080 recalls

FDA records 1 decision for Clearwater Clinical Limited (Calgary, Alberta, CA) in 2008: 1 510(k) clearance. All are in product code LXV (Apparatus, Vestibular Analysis). Its devices cite 3 predicates, 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

How often FDA has decided Clearwater Clinical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Clearwater Clinical Limited by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clearwater Clinical Limited’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 “Clearwater”

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