Cleared Traditional

K901358 - BARD BIOPOTENTIAL AMPLIFIER II

K901358 is an FDA 510(k) clearance for BARD BIOPOTENTIAL AMPLIFIER II, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K901358 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
47d
Days
Class 2
Risk

K901358 is an FDA 510(k) clearance for the BARD BIOPOTENTIAL AMPLIFIER II. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 47 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K901358

510(k) Number K901358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1990
Decision Date May 09, 1990
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 15
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K901358.
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
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · A&D Engineering, Inc. · Mar 1987
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
K864320 · Cordis Corp. · Feb 1987
EXTERNAL VALVE FUNCTION BLOCK
K830914 · Honeywell, Inc. · Aug 1983