Cleared Traditional

K221826 - BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

K221826 is an FDA 510(k) clearance for BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30), manufactured by Becton, Dickinson and Company. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K221826 · Becton, Dickinson and Company · Microbiology device
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Dec 2022
Decision
181d
Days
Class 2
Risk

K221826 is an FDA 510(k) clearance for the BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30). Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on December 21, 2022 after a review of 181 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K221826

510(k) Number K221826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2022
Decision Date December 21, 2022
Days to Decision 181 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
79d slower than avg
Panel avg: 102d · This submission: 181d
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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K221826.
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
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K230651 · Becton, Dickinson and Company · Jun 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · Hardy Diagnostics · Jun 2023
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · Oxoid Limited (Part of Thermo Fisher Scientific) · Sep 2022
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · Oxoid Limited (Part of Thermo Fisher Scientific) · Oct 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · Oxoid Limited (Part of Thermo Fisher Scientific) · Jul 2021