Cleared Special

CRY-ACTRACKERCAM (K110305) - FDA 510(k) Clearance

Class I General Hospital device.

K110305 · Brymill Cryogenic Cystems · General Hospital
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Jan 2012
Decision
345d
Days
Class 1
Risk

K110305 is an FDA 510(k) clearance for the CRY-ACTRACKERCAM. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Brymill Cryogenic Cystems (Ellington, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2900 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brymill Cryogenic Cystems devices

Submission Details

510(k) Number K110305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2011
Decision Date January 13, 2012
Days to Decision 345 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 129d · This submission: 345d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FQZ Thermometer, Clinical Color Change
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.