Cleared Traditional

K231994 - Sensititre 18-24 hour MIC or Breakpoint...

K231994 is an FDA 510(k) clearance for Sensititre 18-24 hour MIC or Breakpoint..., manufactured by Thermo Fisher Scientific. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K231994 · Thermo Fisher Scientific · Microbiology device
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Aug 2023
Decision
51d
Days
Class 2
Risk

K231994 is an FDA 510(k) clearance for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-.... Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on August 25, 2023 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Thermo Fisher Scientific devices

FDA 510(k) Submission Details - K231994

510(k) Number K231994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2023
Decision Date August 25, 2023
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 391
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K231994.
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K223844 · Thermo Fisher Scientific · Mar 2023