Cleared Traditional

K851077 - CARDIAC COOLING JACKET

K851077 is an FDA 510(k) clearance for CARDIAC COOLING JACKET, manufactured by Pat O. Daily. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K851077 · Pat O. Daily · Cardiovascular device
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Jul 1985
Decision
115d
Days
Class 1
Risk

K851077 is an FDA 510(k) clearance for the CARDIAC COOLING JACKET. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Pat O. Daily (San Diego, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Pat O. Daily devices

FDA 510(k) Submission Details - K851077

510(k) Number K851077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1985
Decision Date July 11, 1985
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

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 33
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K851077.
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672 · American Bentley · Mar 1986
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113 · American Bentley · Jan 1986
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · Gambro, Inc. · Sep 1985
COBE GAS FILTER
K851289 · Cobe Laboratories, Inc. · Jun 1985
TUBE TENDER
K841296 · The Anspach Effort, Inc. · Jun 1984
HOLDER FOR BOS-10, 10S 5S
K841812 · American Bentley · Jun 1984