Cleared Traditional

CRYOBAG (K915471) - FDA 510(k) Clearance

K915471 · Janus Biomedical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
817d
Days
-
Risk

K915471 is an FDA 510(k) clearance for the CRYOBAG. Classified as Container, Frozen Donor Tissue Storage (product code LPZ).

Submitted by Janus Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on March 2, 1994 after a review of 817 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 General Hospital submissions.

View all Janus Biomedical, Inc. devices

Submission Details

510(k) Number K915471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1991
Decision Date March 02, 1994
Days to Decision 817 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
688d slower than avg
Panel avg: 129d · This submission: 817d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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