Cleared Traditional

REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG (K935975) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935975 · Remel, Inc. · Microbiology device
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Sep 1994
Decision
280d
Days
Class 2
Risk

K935975 is an FDA 510(k) clearance for the REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 280 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 Remel, Inc. devices

Submission Details

510(k) Number K935975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date September 19, 1994
Days to Decision 280 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 102d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 - JTN Susceptibility Test Discs, Antimicrobial

All 210
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K935975.
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · Remel Co. · Feb 1996
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · Difco Laboratories, Inc. · Dec 1994
DRYSLIDE CEFIN
K930702 · Difco Laboratories, Inc. · Dec 1993
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · Remel Co. · Nov 1993
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK
K933657 · Remel Co. · Oct 1993