Cleared Traditional

K915471 - CRYOBAG

K915471 · Janus Biomedical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K915471

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
688d slower than avg
Panel avg: 129d · This submission: 817d
Pathway characteristics
Predicate-based equivalence.

LPZ Device Classification - Class 0,

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

Regulatory Peers - LPZ Container, Frozen Donor Tissue Storage

Devices cleared under the same product code (LPZ) and FDA review panel - the closest regulatory comparables to K915471.
CRYOBAG, MODEL CB
K021702 · Origen Biomedical, Inc. · Aug 2002
TAMPER HAMPER
K863872 · Hydro-Med Products, Inc. · Feb 1987
ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE
K861761 · Travenol Laboratories, S.A. · Aug 1986
AMPU-PAK
K860511 · Ammerman Medical Enterprises, Inc. · Aug 1986
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
K853663 · Travenol Laboratories, S.A. · Apr 1986
K915471 · CRYOBAG
Download PDF FDA Summary Janus Biomedical, Inc.