Cleared Traditional

K811368 - CARDIOPLEGIA COOLING & ADMIN. SETS

K811368 is the FDA 510(k) clearance for CARDIOPLEGIA COOLING & ADMIN. SETS by Bentley Laboratories, Inc.. It is a Class 1 Cardiovascular device (product code KRI) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K811368 · Bentley Laboratories, Inc. · Cardiovascular device
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Jun 1981
Decision
26d
Days
Class 1
Risk

K811368 is an FDA 510(k) clearance for the CARDIOPLEGIA COOLING & ADMIN. SETS. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 26 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K811368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1981
Decision Date June 09, 1981
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K811368.
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167 · American Bentley · Mar 1983
D645-BACTERIOLOGICAL GAS LINE FILTER
K822097 · Electromedics, Inc. · Jul 1982
TMO INTEGRATED CIRCUIT SYSTEM
K820406 · Travenol Laboratories, S.A. · Mar 1982
CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
K811348 · Bentley Laboratories, Inc. · May 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · 3M Health Care, Sarns · Jan 1981
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906 · C.R. Bard, Inc. · Dec 1980