Cleared Traditional

K841079 - WILLIAM HARVEY H-4700 FILTER/CARDIO

K841079 is the FDA 510(k) clearance for WILLIAM HARVEY H-4700 FILTER/CARDIO by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K841079 · C.R. Bard, Inc. · Cardiovascular device
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Apr 1984
Decision
35d
Days
Class 2
Risk

K841079 is an FDA 510(k) clearance for the WILLIAM HARVEY H-4700 FILTER/CARDIO. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 K841079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date April 17, 1984
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 126
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K841079.
CARDIOPLEGIA RESERVOIR CAS-2000
K841938 · American Bentley · Aug 1984
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT
K841031 · American Bentley · May 1984
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K841175 · C.R. Bard, Inc. · Apr 1984
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
K834373 · American Bentley · Feb 1984
USE OF TWEEN 80 AS A WETTING AGENT ON
K832802 · American Bentley · Dec 1983
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K832671 · Cobe Laboratories, Inc. · Dec 1983