Cleared Traditional

K840023 - TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC

K840023 is the FDA 510(k) clearance for TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC by American Bentley. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K840023 · American Bentley · Cardiovascular device
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Jun 1984
Decision
169d
Days
Class 2
Risk

K840023 is an FDA 510(k) clearance for the TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by American Bentley (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 169 days - an extended review cycle.

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 American Bentley devices

Submission Details

510(k) Number K840023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date June 22, 1984
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 32
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K840023.
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · Honeywell, Inc. · Aug 1985
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C
K840121 · Hewlett-Packard Co. · May 1984
CARDIOFAX ECG 6543
K840274 · Nihon Kohden America, Inc. · Apr 1984
DISPOSABLE MANIFOLD SET
K832657 · Mallinckrodt Critical Care · Nov 1983