Cleared Traditional

K203700 - Thermo Scientific Oxoid Cefiderocol Dis...

K203700 is the FDA 510(k) clearance for Thermo Scientific Oxoid Cefiderocol Dis... by Oxoid Limited (Part of Thermo Fisher Scientific). It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K203700 · Oxoid Limited (Part of Thermo Fisher Scientific) · Microbiology device
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Jul 2021
Decision
224d
Days
Class 2
Risk

K203700 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Oxoid Limited (Part of Thermo Fisher Scientific) (Basingstoke, GB). The FDA issued a Cleared decision on July 30, 2021 after a review of 224 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 Oxoid Limited (Part of Thermo Fisher Scientific) devices

Submission Details

510(k) Number K203700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date July 30, 2021
Days to Decision 224 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 102d · This submission: 224d
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 K203700.
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · Becton, Dickinson and Company · Dec 2022
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 Eravacycline Disc (20ug) ERV20
K193508 · Oxoid Limited (Part of Thermo Fisher Scientific) · Dec 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · Hardy Diagnostics · Jan 2020
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · Hardy Diagnostics · Sep 2019