Cleared Traditional

K802906 - WILLIAM HARVEY OXYGENATING GAS FILTER

K802906 is the FDA 510(k) clearance for WILLIAM HARVEY OXYGENATING GAS FILTER by C.R. Bard, Inc.. It is a Class 1 Cardiovascular device (product code KRI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K802906 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
29d
Days
Class 1
Risk

K802906 is an FDA 510(k) clearance for the WILLIAM HARVEY OXYGENATING GAS FILTER. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - 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 K802906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date December 16, 1980
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 23
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K802906.
CARDIOPLEGIA COOLING & ADMIN. SETS
K811368 · Bentley Laboratories, Inc. · Jun 1981
CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
K811348 · Bentley Laboratories, Inc. · May 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · 3M Health Care, Sarns · Jan 1981
SHILEY QUICK DISCONNECT ASSEMBLY
K791829 · Shiley, Inc. · Oct 1979
FILTER, EXTRACORPOREAL BLOOD HOLDER
K781861 · Surgikos, Inc. · Nov 1978
PVC QUICK PRIME LINES
K780984 · Norton Performance Plastics Corp. · Jul 1978