Cleared Traditional

K874441 - BARD BIOPOTENTIAL AMPLIFIER

K874441 is the FDA 510(k) clearance for BARD BIOPOTENTIAL AMPLIFIER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DRR) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K874441 · C.R. Bard, Inc. · Cardiovascular device
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Jan 1988
Decision
83d
Days
Class 2
Risk

K874441 is an FDA 510(k) clearance for the BARD BIOPOTENTIAL AMPLIFIER. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2050 - 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

Submission Details

510(k) Number K874441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date January 19, 1988
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRR Amplifier And Signal Conditioner, Biopotential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2050
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 - DRR Amplifier And Signal Conditioner, Biopotential

All 9
Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K874441.
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K771976 · G.D. Searle and Co. · Nov 1977