Cleared Traditional

K953223 - PIPERACILIN TAZOBACTAM 4 UG

K953223 is an FDA 510(k) clearance for PIPERACILIN TAZOBACTAM 4 UG, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K953223 · Ab Biodisk · Microbiology device
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Aug 1995
Decision
123d
Days
Class 2
Risk

K953223 is an FDA 510(k) clearance for the PIPERACILIN TAZOBACTAM 4 UG. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on August 15, 1995 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Ab Biodisk devices

FDA 510(k) Submission Details - K953223

510(k) Number K953223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1995
Decision Date August 15, 1995
Days to Decision 123 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 102d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K953223.
AMOXICILLIN/CLAVULANIC ACID 2/1
K954319 · Ab Biodisk · Dec 1995
JUSTONE
K951240 · Radiometer America, Inc. · Oct 1995
HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K951241 · Radiometer America, Inc. · Oct 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · Baxter Diagnostics, Inc. · Jul 1995
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · Radiometer America, Inc. · Jul 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · Ab Biodisk · Jul 1995