Cleared Traditional

K935166 - FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER

K935166 is an FDA 510(k) clearance for FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER, manufactured by Millar Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K935166 · Millar Instruments, Inc. · Cardiovascular device
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Aug 1994
Decision
282d
Days
Class 2
Risk

K935166 is an FDA 510(k) clearance for the FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER. 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 August 5, 1994 after a review of 282 days - an extended review cycle.

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.

View all Millar Instruments, Inc. devices

FDA 510(k) Submission Details - K935166

510(k) Number K935166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date August 05, 1994
Days to Decision 282 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
157d slower than avg
Panel avg: 125d · This submission: 282d
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 Peers - DXO Transducer, Pressure, Catheter Tip

All 55
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K935166.
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PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
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INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · Becton Dickinson Vascular Access, Inc. · Apr 1994
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
K924737 · Becton Dickinson Vascular Access, Inc. · Aug 1993