Cleared Traditional

K860511 - AMPU-PAK

K860511 · Ammerman Medical Enterprises, Inc. · General Hospital
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Aug 1986
Decision
174d
Days
-
Risk

K860511 is an FDA 510(k) clearance for the AMPU-PAK. Classified as Container, Frozen Donor Tissue Storage (product code LPZ).

Submitted by Ammerman Medical Enterprises, Inc. (Naples, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ammerman Medical Enterprises, Inc. devices

FDA 510(k) Submission Details - K860511

510(k) Number K860511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date August 04, 1986
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

LPZ Device Classification - Class 0,

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