Cleared Traditional

K840023 - TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC

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

K840023 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K840023

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
Combination Product No
PCCP Authorized No
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.

DRS Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K840023.
PRESSURE MONITORING KIT
K842352 · Utah Medical Products, Inc. · Mar 1985
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984
DESERET DISPOSABLE PRESSURE TRANSDUCER
K841968 · Parke-Davis Co. · Aug 1984
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C
K840121 · Hewlett-Packard Co. · May 1984
CARDIOFAX ECG 6543
K840274 · Nihon Kohden America, Inc. · Apr 1984
MODEL TTPM TIME TEMP. PRESSURE MONITOR
K832897 · Electromedics, Inc. · Mar 1984