Cleared Traditional

K894286 - PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER

K894286 is an FDA 510(k) clearance for PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCE..., manufactured by Ppg Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K894286 · Ppg Industries, Inc. · Cardiovascular device
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Oct 1989
Decision
111d
Days
Class 2
Risk

K894286 is an FDA 510(k) clearance for the PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Pleasantville, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 111 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.

View all Ppg Industries, Inc. devices

FDA 510(k) Submission Details - K894286

510(k) Number K894286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date October 12, 1989
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
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 52
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K894286.
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · Baxter Healthcare Corp · Jul 1991
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · Millar Instruments, Inc. · Dec 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · Deseret Medical, Inc. · Oct 1989
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · Ppg Industries, Inc. · Oct 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988