Cleared Traditional

K811732 - THIOTONE PEPTONE

K811732 is the FDA 510(k) clearance for THIOTONE PEPTONE by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSK) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K811732 · Acumedia Manufacturers, Inc. · Microbiology device
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Jul 1981
Decision
14d
Days
Class 1
Risk

K811732 is an FDA 510(k) clearance for the THIOTONE 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 14 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 K811732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1981
Decision Date July 02, 1981
Days to Decision 14 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
88d faster than avg
Panel avg: 102d · This submission: 14d
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 K811732.
POLYPEPTONE PEPTONE
K811652 · Acumedia Manufacturers, Inc. · Jul 1981
PHYTONE
K811653 · Acumedia Manufacturers, Inc. · Jul 1981
BIOSATE
K811730 · Acumedia Manufacturers, Inc. · Jul 1981
LEGIONELLA, GROWTH & SELECTIVE, SUPP.
K811516 · Oxoid U.S.A., Inc. · Jun 1981
VCN SUPPLEMENT
K811517 · Oxoid U.S.A., Inc. · Jun 1981
VCNT ANTIBIOTIC SUPPLEMENT
K811518 · Oxoid U.S.A., Inc. · Jun 1981