Cleared Traditional

K961364 - AUTOMATIC TUBING CLAMP SYSTEM (ATC)

K961364 is an FDA 510(k) clearance for AUTOMATIC TUBING CLAMP SYSTEM (ATC), manufactured by Rocky Mountain Research, Inc.. The device is a Class 2 Cardiovascular device with product code KRL cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K961364 · Rocky Mountain Research, Inc. · Cardiovascular device
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Oct 1996
Decision
205d
Days
Class 2
Risk

K961364 is an FDA 510(k) clearance for the AUTOMATIC TUBING CLAMP SYSTEM (ATC). Classified as Detector, Bubble, Cardiopulmonary Bypass (product code KRL), Class II - Special Controls.

Submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 205 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4205 - 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 Rocky Mountain Research, Inc. devices

FDA 510(k) Submission Details - K961364

510(k) Number K961364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date October 31, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRL Device Classification - Class 2, Special Controls

Product Code KRL Detector, Bubble, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4205
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 - KRL Detector, Bubble, Cardiopulmonary Bypass

All 7
Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K961364.
SARNS ULTRASONIC AIR SENSOR
K940651 · 3M Health Care, Sarns · May 1994
SARNS AIR DETECTION SYSTEM
K935977 · 3M Health Care, Sarns · Feb 1994
CAPIOX(R) BUBBLE TRAP
K911632 · Terumo Medical Corp. · Jul 1991
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · Shiley, Inc. · Feb 1987
COBE ACCESSORY INTERFACE MODULE (AIM)
K861860 · Cobe Laboratories, Inc. · Jul 1986
COBE AEPS
K842054 · Cobe Laboratories, Inc. · Aug 1984