Cleared Traditional

K992077 - PASCO MIC AND MIC/ID PANELS (OFLOXACIN)

K992077 is the FDA 510(k) clearance for PASCO MIC AND MIC/ID PANELS (OFLOXACIN) by Pasco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K992077 · Pasco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
74d
Days
Class 2
Risk

K992077 is an FDA 510(k) clearance for the PASCO MIC AND MIC/ID PANELS (OFLOXACIN). Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 74 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 Pasco Laboratories, Inc. devices

Submission Details

510(k) Number K992077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1999
Decision Date September 03, 1999
Days to Decision 74 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 102d · This submission: 74d
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 283
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K992077.
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · Pasco Laboratories, Inc. · Oct 1999
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
K992507 · Pasco Laboratories, Inc. · Oct 1999
MODIFICATION OF PASCO MIC AND MIC/ID PANELS
K992420 · Pasco Laboratories, Inc. · Sep 1999
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
K992297 · Pasco Laboratories, Inc. · Sep 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · Pasco Laboratories, Inc. · Aug 1999
TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984513 · Oxoid , Ltd. · Apr 1999