Cleared Traditional

K873593 - BIOSURE SPECIMEN COLLECTION CONTAINER (FDA 510(k) Clearance)

Class I Pathology device.

K873593 · Biosure, Inc. · Pathology device
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Nov 1987
Decision
82d
Days
Class 1
Risk

K873593 is an FDA 510(k) clearance for the BIOSURE SPECIMEN COLLECTION CONTAINER. Classified as Container, Specimen Mailer And Storage, Sterile (product code KDT), Class I - General Controls.

Submitted by Biosure, Inc. (San Jose, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3250 - the FDA pathology 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 Biosure, Inc. devices

Submission Details

510(k) Number K873593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date November 25, 1987
Days to Decision 82 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 77d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDT Container, Specimen Mailer And Storage, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3250
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.