Cleared Traditional

PLASMA POOLER HEAT SEALER (K820301) - FDA 510(k) Clearance

Class I Hematology device.

K820301 · North American Biologicals, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
64d
Days
Class 1
Risk

K820301 is an FDA 510(k) clearance for the PLASMA POOLER HEAT SEALER. Classified as Device, Heat-sealing (product code KSD), Class I - General Controls.

Submitted by North American Biologicals, Inc. (Walker, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9750 - 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: 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 North American Biologicals, Inc. devices

Submission Details

510(k) Number K820301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1982
Decision Date April 09, 1982
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KSD Device, Heat-sealing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.9750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.