Cleared Traditional

K841032 - HOLDER FOR MODELS AF-10

K841032 is the FDA 510(k) clearance for HOLDER FOR MODELS AF-10 by American Bentley. It is a Class 1 Cardiovascular device (product code KRI) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K841032 · American Bentley · Cardiovascular device
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Apr 1984
Decision
36d
Days
Class 1
Risk

K841032 is an FDA 510(k) clearance for the HOLDER FOR MODELS AF-10,1025,1040,5. 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 April 17, 1984 after a review of 36 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 K841032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date April 17, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 11
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K841032.
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
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GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
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COBE GAS FILTER
K851289 · Cobe Laboratories, Inc. · Jun 1985
SHILEY GAS FILTER
K832704 · Shiley, Inc. · Sep 1983
TMO INTEGRATED CIRCUIT SYSTEM
K820406 · Travenol Laboratories, S.A. · Mar 1982
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · 3M Health Care, Sarns · Jan 1981