Cleared Traditional

PREGNOPOST (K821621) - FDA 510(k) Clearance

Class I Chemistry device.

K821621 · M.M. Wolfred, Ph.D. · Chemistry device
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Jul 1982
Decision
49d
Days
Class 1
Risk

K821621 is an FDA 510(k) clearance for the PREGNOPOST. Classified as Container, Specimen Mailer And Storage, Sterile (product code KDT), Class I - General Controls.

Submitted by M.M. Wolfred, Ph.D. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1982 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.3250 - the FDA in vitro diagnostics and chemistry 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 M.M. Wolfred, Ph.D. devices

Submission Details

510(k) Number K821621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date July 21, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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.