Cleared Traditional

K811652 - POLYPEPTONE PEPTONE

K811652 is the FDA 510(k) clearance for POLYPEPTONE PEPTONE by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSK) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811652 · Acumedia Manufacturers, Inc. · Microbiology device
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Jul 1981
Decision
22d
Days
Class 1
Risk

K811652 is an FDA 510(k) clearance for the POLYPEPTONE PEPTONE. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K811652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1981
Decision Date July 02, 1981
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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 - JSK Supplement, Culture Media

All 56
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K811652.
G-N ANAEROBE SUPPLEMENT
K822462 · Oxoid U.S.A., Inc. · Sep 1982
YERSINIA SELECTIVE SUPPLEMENT
K822511 · Gibco Laboratories Life Technologies, Inc. · Sep 1982
GELYSATE
K811649 · Acumedia Manufacturers, Inc. · Jul 1981
PHYTONE
K811653 · Acumedia Manufacturers, Inc. · Jul 1981
BIOSATE
K811730 · Acumedia Manufacturers, Inc. · Jul 1981
THIOTONE PEPTONE
K811732 · Acumedia Manufacturers, Inc. · Jul 1981