Cleared Traditional

K080998 - DORIPENEM 10UG BBL SENSI-DISC

K080998 is an FDA 510(k) clearance for DORIPENEM 10UG BBL SENSI-DISC, manufactured by Becton, Dickinson & CO. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K080998 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
35d
Days
Class 2
Risk

K080998 is an FDA 510(k) clearance for the DORIPENEM 10UG BBL SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on May 12, 2008 after a review of 35 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 Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K080998

510(k) Number K080998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date May 12, 2008
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
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 313
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K080998.
HARDYDISK AST TELAVANCIN,30UG
K093807 · Hardy Diagnostics · Jan 2010
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · Becton, Dickinson & CO · Oct 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · Becton, Dickinson & CO · Oct 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · Hardy Diagnostics · Jan 2008
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K070262 · Oxoid , Ltd. · Mar 2007
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · Hardy Diagnostics · Aug 2006