Cleared Traditional

BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR (K862920) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862920 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
59d
Days
Class 2
Risk

K862920 is an FDA 510(k) clearance for the BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 59 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 K862920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date September 29, 1986
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 168
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K862920.
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · Sorin Group Italia S.R.L. · Dec 2025
Quantum Perfusion Hybrid System
K241206 · Spectrum Medical S.R.L. · Jul 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · Medtronic Cardiac Surgery · May 2024
BMR 1900 PHISIO
K223361 · Sorin Group Italia S.R.L. · Jun 2023
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · Medtronic, Inc. · Mar 2017
Intersept Filtered Cardiotomy Reservoir
K151110 · Medtronic, Inc. · May 2015