Cleared Abbreviated

MIKRO-CATH, MODEL 825-0101 (K093111) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K093111 · Millar Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
96d
Days
Class 2
Risk

K093111 is an FDA 510(k) clearance for the MIKRO-CATH, MODEL 825-0101. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on January 5, 2010 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Millar Instruments, Inc. devices

Submission Details

510(k) Number K093111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date January 05, 2010
Days to Decision 96 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXO Transducer, Pressure, Catheter Tip

All 63
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K093111.
OptoMonitor 3
K251367 · Opsens, Inc. · Jan 2026
OptoMonitor 3
K241418 · Opsens, Inc. · Feb 2025
ACIST RXi System (016616)
K233904 · Acist Medical Systems, Inc. · Jul 2024
TruWave Disposable Pressure Transducer
K222216 · Edwards Lifesciences, LLC · Dec 2022
OptoMonitor 3
K202943 · Opsens, Inc. · Nov 2020
OptoMonitor 3
K193620 · Opsens, Inc. · Jun 2020