Cleared Traditional

K830167 - HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-

K830167 is an FDA 510(k) clearance for HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-, manufactured by American Bentley. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K830167 · American Bentley · Cardiovascular device
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Mar 1983
Decision
52d
Days
Class 1
Risk

K830167 is an FDA 510(k) clearance for the HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-. 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 March 11, 1983 after a review of 52 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

FDA 510(k) Submission Details - K830167

510(k) Number K830167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date March 11, 1983
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 30
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K830167.
HOLDER FOR MODELS AF-10,1025,1040,5
K841032 · American Bentley · Apr 1984
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TMO INTEGRATED CIRCUIT SYSTEM
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CARDIOPLEGIA COOLING & ADMIN. SETS
K811368 · Bentley Laboratories, Inc. · Jun 1981