Cleared Traditional

K832384 - BP TRANSDUCER HOLDERS TH-2,3 & 4

K832384 is an FDA 510(k) clearance for BP TRANSDUCER HOLDERS TH-2, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K832384 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
118d
Days
Class 2
Risk

K832384 is an FDA 510(k) clearance for the BP TRANSDUCER HOLDERS TH-2,3 & 4. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by American Bentley (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 118 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 American Bentley devices

FDA 510(k) Submission Details - K832384

510(k) Number K832384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date November 14, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
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 K832384.
VSM R1
K842213 · Physio-Control Corp. · Oct 1984
MODEL 110-5 & 140-8
K842005 · Camino Laboratories, Inc. · Aug 1984
MINATURE PRESSURE TRANSDUCER
K834040 · Carbomedics, Inc. · Feb 1984
PHYSIOLOGICAL PRESS. MEASUREMENT CATH
K832579 · Camino Laboratories, Inc. · Oct 1983
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH
K832604 · Camino Laboratories, Inc. · Oct 1983
PHYSIOLOGICAL PRESSURE MEASUREMENT SYS
K830638 · Camino Laboratories, Inc. · Apr 1983