Cleared Traditional

K850898 - MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER

K850898 is the FDA 510(k) clearance for MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER by Medi-Trace Products Division. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K850898 · Medi-Trace Products Division · Cardiovascular device
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Jul 1985
Decision
143d
Days
Class 2
Risk

K850898 is an FDA 510(k) clearance for the MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Medi-Trace Products Division (Buffalo, US). The FDA issued a Cleared decision on July 25, 1985 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Medi-Trace Products Division devices

Submission Details

510(k) Number K850898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1985
Decision Date July 25, 1985
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 79
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K850898.
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
K851486 · Gould, Inc. · Oct 1985
BENTLEY-TRANTEC DISPOS. DOMES D-260-
K841811 · American Bentley · Sep 1985
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · Honeywell, Inc. · Aug 1985
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO
K843580 · Graphic Controls Corp. · May 1985
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · Utah Medical Products, Inc. · Mar 1985