Cleared Traditional

CRYOBAG, MODEL CB (K021702) - FDA 510(k) Clearance

K021702 · Origen Biomedical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
75d
Days
-
Risk

K021702 is an FDA 510(k) clearance for the CRYOBAG, MODEL CB. Classified as Container, Frozen Donor Tissue Storage (product code LPZ).

Submitted by Origen Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Origen Biomedical, Inc. devices

Submission Details

510(k) Number K021702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2002
Decision Date August 06, 2002
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LPZ Container, Frozen Donor Tissue Storage
Device Class -