Cleared Traditional

K832411 - GASLINE FILTER #GF-10

K832411 is an FDA 510(k) clearance for GASLINE FILTER #GF-10, 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 53-day FDA review.

K832411 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
53d
Days
Class 1
Risk

K832411 is an FDA 510(k) clearance for the GASLINE FILTER #GF-10. 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 September 12, 1983 after a review of 53 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 - K832411

510(k) Number K832411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1983
Decision Date September 12, 1983
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K832411.
HOLDER FOR BOS-10, 10S 5S
K841812 · American Bentley · Jun 1984
HOLDER FOR MODELS AF-10,1025,1040,5
K841032 · American Bentley · Apr 1984
SHILEY GAS FILTER
K832704 · Shiley, Inc. · Sep 1983
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167 · American Bentley · Mar 1983
D645-BACTERIOLOGICAL GAS LINE FILTER
K822097 · Electromedics, Inc. · Jul 1982
TMO INTEGRATED CIRCUIT SYSTEM
K820406 · Travenol Laboratories, S.A. · Mar 1982