Cleared Traditional

CRYO Arctic, CRYO Penguin (K203661) - FDA 510(k) Clearance

K203661 · Cryoscience North America, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
526d
Days
-
Risk

K203661 is an FDA 510(k) clearance for the CRYO Arctic, CRYO Penguin. Classified as Vapocoolant Device (product code MLY).

Submitted by Cryoscience North America, Inc. (Houston, US). The FDA issued a Cleared decision on May 25, 2022 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Cryoscience North America, Inc. devices

Submission Details

510(k) Number K203661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2020
Decision Date May 25, 2022
Days to Decision 526 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
411d slower than avg
Panel avg: 115d · This submission: 526d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Consultant

Qpm Consulting, LLC
Robert Seiple

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 7
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