Cleared Traditional

K841812 - HOLDER FOR BOS-10, 10S 5S (FDA 510(k) Clearance)

Class I Cardiovascular device.

K841812 · American Bentley · Cardiovascular device
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Jun 1984
Decision
41d
Days
Class 1
Risk

K841812 is an FDA 510(k) clearance for the HOLDER FOR BOS-10, 10S 5S. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by American Bentley (Mchenry, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 41 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 American Bentley devices

Submission Details

510(k) Number K841812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date June 11, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
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.