Cleared Traditional

K844383 - KANAMYCIN 1000 MCG DIFFERENTIAL DISK

K844383 is the FDA 510(k) clearance for KANAMYCIN 1000 MCG DIFFERENTIAL DISK by Anaerobe Systems. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K844383 · Anaerobe Systems · Microbiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jan 1985

Decision

52d

Days

Class 1

Risk

K844383 is an FDA 510(k) clearance for the KANAMYCIN 1000 MCG DIFFERENTIAL DISK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Anaerobe Systems (Walker, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Anaerobe Systems devices

Submission Details

510(k) Number	K844383 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1984
Decision Date	January 04, 1985
Days to Decision	52 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

50d faster than avg

Panel avg: 102d · This submission: 52d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 866.2660

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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 147

Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K844383.

BILE DIFFERENTIAL DISK

K844380 · Anaerobe Systems · Jan 1985

COLISTIN 10 MCG. DIFFERENTIAL DISK

K844381 · Anaerobe Systems · Jan 1985

VANCOMYCIN 5MCG DIFFERENTIAL DISK

K844382 · Anaerobe Systems · Jan 1985

PYRIDOXAL DISC

K844020 · Remel Co. · Dec 1984

STREP ID TRIPLATE

K844019 · Remel Co. · Oct 1984

PYR BROTH

K843987 · Remel Co. · Oct 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K844383

Anaerobe Systems

Walker, MI · US

MARION E COX

Regulatory profile

52 submissions 52 cleared

100% clearance rate · Active in Microbiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active