Cleared Traditional

K801063 - HALL ARTERIAL OSCILLATOR

K801063 is an FDA 510(k) clearance for HALL ARTERIAL OSCILLATOR, manufactured by American Sterilizer Co.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K801063 · American Sterilizer Co. · Cardiovascular device
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Sep 1980
Decision
143d
Days
Class 2
Risk

K801063 is an FDA 510(k) clearance for the HALL ARTERIAL OSCILLATOR. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by American Sterilizer Co. (Walker, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 American Sterilizer Co. devices

FDA 510(k) Submission Details - K801063

510(k) Number K801063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1980
Decision Date September 26, 1980
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWX Device Classification - Class 2, Special Controls

Product Code DWX Stripper, Artery, Intraluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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.