Cleared Traditional

K913875 - BARD(R) BIOPOTENTIAL AMPLIFIER II

K913875 is an FDA 510(k) clearance for BARD BIOPOTENTIAL AMPLIFIER II, manufactured by Bard Electrophysiology. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913875 · Bard Electrophysiology · Cardiovascular device
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Nov 1991
Decision
90d
Days
Class 2
Risk

K913875 is an FDA 510(k) clearance for the BARD(R) BIOPOTENTIAL AMPLIFIER II. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Bard Electrophysiology (Tewksbury, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2060 - 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 Bard Electrophysiology devices

FDA 510(k) Submission Details - K913875

510(k) Number K913875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1991
Decision Date November 27, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRQ Device Classification - Class 2, Special Controls

Product Code DRQ Amplifier And Signal Conditioner, Transducer Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2060
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 - DRQ Amplifier And Signal Conditioner, Transducer Signal

All 16
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K913875.
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
K013205 · Millar Instruments, Inc. · Jul 2002
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
K020277 · Siemens Medical Solutions USA, Inc. · Feb 2002
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · Siemens Medical Solutions USA, Inc. · Mar 2001
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · C.R. Bard, Inc. · May 1990
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · A&D Engineering, Inc. · Mar 1987
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
K864320 · Cordis Corp. · Feb 1987