Cleared Traditional

K811377 - PARA-PAK

K811377 is the FDA 510(k) clearance for PARA-PAK by Meridian Diagnostics, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K811377 · Meridian Diagnostics, Inc. · Microbiology device
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Jun 1981
Decision
32d
Days
Class 2
Risk

K811377 is an FDA 510(k) clearance for the PARA-PAK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 32 days - a notably fast clearance 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: 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 Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K811377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1981
Decision Date June 16, 1981
Days to Decision 32 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
70d faster than avg
Panel avg: 102d · This submission: 32d
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 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K811377.
MOXALACTAM 30MCG. SENSI-DISC
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MEZLOCILLIN 75 MCG. SENSI-DISC
K812571 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
MEZLOCILLIN 75 MCG. SENSITIVITY DISCS
K812525 · Difco Laboratories, Inc. · Oct 1981
CEFOTAXIME 30 MCG. SENSITIVITY DISCS.
K810546 · Difco Laboratories, Inc. · Mar 1981
CEFOTAXIME 30 MCG. SENSI-DISC.
K810564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
MINOCYCLINE 30MCG. SENSI DISC
K802194 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980