Cleared Traditional

K935975 - REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG

K935975 is an FDA 510(k) clearance for REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG, manufactured by Remel, Inc.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 280-day FDA review.

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

FDA 510(k) Submission Details - K935975

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.

JTN Device Classification - Class 2, Special Controls

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 314
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K935975.
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
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
K943407 · Becton Dickinson Microbiology Systems · Oct 1994
PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC
K940359 · Becton Dickinson Microbiology Systems · Mar 1994
DRYSLIDE CEFIN
K930702 · Difco Laboratories, Inc. · Dec 1993
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · Remel Co. · Nov 1993