Cleared Traditional

K850218 - SWIM'S S-77 POWDER MEDIUM

K850218 is the FDA 510(k) clearance for SWIM'S S-77 POWDER MEDIUM by Hazleton Research Products, Inc.. It is a Class 1 Microbiology device (product code KIT) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K850218 · Hazleton Research Products, Inc. · Microbiology device
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Mar 1985
Decision
44d
Days
Class 1
Risk

K850218 is an FDA 510(k) clearance for the SWIM'S S-77 POWDER MEDIUM. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2220 - 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 Hazleton Research Products, Inc. devices

Submission Details

510(k) Number K850218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date March 07, 1985
Days to Decision 44 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
58d faster than avg
Panel avg: 102d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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 - KIT Media And Components, Synthetic Cell And Tissue Culture

All 304
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