Cleared Traditional

K870133 - HY PBC FLASK

K870133 is an FDA 510(k) clearance for HY PBC FLASK, manufactured by Hy Laboratories, Ltd.. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K870133 · Hy Laboratories, Ltd. · Microbiology device
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Feb 1987
Decision
24d
Days
Class 1
Risk

K870133 is an FDA 510(k) clearance for the HY PBC FLASK. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Hy Laboratories, Ltd. (Rehovot 76326, IL). The FDA issued a Cleared decision on February 5, 1987 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Hy Laboratories, Ltd. devices

FDA 510(k) Submission Details - K870133

510(k) Number K870133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1987
Decision Date February 05, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 102d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

JSG Device Classification - Class 1, General Controls

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 190
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K870133.
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