Cleared Traditional

K770937 - PUMP, BYPASS, PULSATILE, AVCO

K770937 is an FDA 510(k) clearance for PUMP, manufactured by Avco Medical Products. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K770937 · Avco Medical Products · Cardiovascular device
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Nov 1977
Decision
178d
Days
Class 2
Risk

K770937 is an FDA 510(k) clearance for the PUMP, BYPASS, PULSATILE, AVCO. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Avco Medical Products (Mchenry, US). The FDA issued a Cleared decision on November 17, 1977 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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.

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FDA 510(k) Submission Details - K770937

510(k) Number K770937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1977
Decision Date November 17, 1977
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFM Device Classification - Class 2, Special Controls

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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.