Cleared Traditional

K790459 - CEMENT DISPENSER CEMENT MIXER

K790459 is an FDA 510(k) clearance for CEMENT DISPENSER CEMENT MIXER, manufactured by Dow Corning Wright. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K790459 · Dow Corning Wright · Microbiology device
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Mar 1979
Decision
23d
Days
Class 1
Risk

K790459 is an FDA 510(k) clearance for the CEMENT DISPENSER CEMENT MIXER. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Dow Corning Wright (Mchenry, US). The FDA issued a Cleared decision on March 28, 1979 after a review of 23 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K790459

510(k) Number K790459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date March 28, 1979
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
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 183
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K790459.
CHOPPED MEAT GLUCOSE MEDIUM
K790621 · Anaerobe Systems · Apr 1979
CHOPPED MEAT AGAR
K790622 · Anaerobe Systems · Apr 1979
BACTERIOLOGICAL CULTURE MEDIA
K790497 · Micro Media Laboratories · Apr 1979
TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
K790375 · Granite Diagnostics, Inc. · Mar 1979
CDC ANAEROBE BLOOD AGAR
K781604 · Anaerobe Systems · Oct 1978
MUELLER HINTON AGAR W/HEMOGLOBIN
K760459 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1976