510(k) Report

FDA applicant

Brymill Cryogenic Cystems

Ellington, CT1 decision2012–20120 recalls

FDA records 1 decision for Brymill Cryogenic Cystems (Ellington, CT) in 2012: 1 510(k) clearance. All are in product code FQZ (Thermometer, Clinical Color Change). 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, general hospital panel, where it files most

How often FDA has decided Brymill Cryogenic Cystems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Brymill Cryogenic Cystems by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Brymill”

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