Cleared Traditional

PHARMAFLEX CRYOGENIC BAG (K792395) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K792395 · Pharmachem Corp. · Hematology device
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Feb 1980
Decision
92d
Days
Class 2
Risk

K792395 is an FDA 510(k) clearance for the PHARMAFLEX CRYOGENIC BAG. Classified as Container, Empty, For Collection & Processing Of Blood & Blood Components (product code KSR), Class II - Special Controls.

Submitted by Pharmachem Corp. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9100 - the FDA hematology device framework. 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmachem Corp. devices

Submission Details

510(k) Number K792395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date February 26, 1980
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.