Cleared Traditional

K822870 - STOOL-COLLECTION/PRESERVATION KIT

K822870 is an FDA 510(k) clearance for STOOL-COLLECTION/PRESERVATION KIT, manufactured by American Scientific Products. The device is a Class 1 Microbiology device with product code KDT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822870 · American Scientific Products · Microbiology device
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Nov 1982
Decision
35d
Days
Class 1
Risk

K822870 is an FDA 510(k) clearance for the STOOL-COLLECTION/PRESERVATION KIT. Classified as Container, Specimen Mailer And Storage, Sterile (product code KDT), Class I - General Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.3250 - the FDA microbiology 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 American Scientific Products devices

FDA 510(k) Submission Details - K822870

510(k) Number K822870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date November 01, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

KDT Device Classification - Class 1, General Controls

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.

Regulatory Peers - KDT Container, Specimen Mailer And Storage, Sterile

All 7
Devices cleared under the same product code (KDT) and FDA review panel - the closest regulatory comparables to K822870.
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