Cleared Traditional

K950346 - B-L RED(TM) DISCS

K950346 is an FDA 510(k) clearance for B-L RED(TM) DISCS, manufactured by Oxis Intl., Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K950346 · Oxis Intl., Inc. · Microbiology device
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May 1995
Decision
98d
Days
Class 1
Risk

K950346 is an FDA 510(k) clearance for the B-L RED(TM) DISCS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxis Intl., Inc. devices

FDA 510(k) Submission Details - K950346

510(k) Number K950346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date May 05, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

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 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K950346.
DRYSLIDE CARTARRHALIS
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K954812 · Microbiologics, Inc. · Dec 1995
LYFO(TM) DIFFERENTIAL DISK
K951889 · Microbiologics, Inc. · Aug 1995
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880 · Microbiologics, Inc. · Apr 1995
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881 · Microbiologics, Inc. · Apr 1995
LYFO(TM) DIFFERENTIAL DISK-BILE
K945882 · Microbiologics, Inc. · Apr 1995