Cleared Traditional

K163376 - Mikro-Cath Pressure Catheter

K163376 is an FDA 510(k) clearance for Mikro-Cath Pressure Catheter, manufactured by Millar, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K163376 · Millar, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
99d
Days
Class 2
Risk

K163376 is an FDA 510(k) clearance for the Mikro-Cath Pressure Catheter. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Millar, Inc. (Houston, US). The FDA issued a Cleared decision on March 10, 2017 after a review of 99 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 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163376

510(k) Number K163376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2016
Decision Date March 10, 2017
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

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 Consultant

Acknowledge Regulatory Strategies
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXO Transducer, Pressure, Catheter Tip

All 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K163376.
TruWave Disposable Pressure Transducer
K183413 · Edwards Lifeciences, LLC · May 2019
PressureWire X
K180558 · St. Jude Medical (Now Part of Abbott Medical) · Mar 2018
TruWave Disposable Pressure Transducer
K171996 · Edwards Lifesciences, LLC · Oct 2017
OptoMonitor II
K161263 · Opsens, Inc. · Sep 2016
PressureWire X Guidewire
K161171 · St. Jude Medical, Inc. · Aug 2016
Comet Pressure Guidewire
K151610 · Boston Scientific Corporation · Oct 2015