Cleared Traditional

K781842 - OXYGENATOR

K781842 is the FDA 510(k) clearance for OXYGENATOR by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K781842 · Bentley Laboratories, Inc. · Cardiovascular device
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Nov 1978
Decision
12d
Days
Class 2
Risk

K781842 is an FDA 510(k) clearance for the OXYGENATOR, BLOOD BOS-10. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K781842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1978
Decision Date November 08, 1978
Days to Decision 12 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
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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.

Regulatory Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 191
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K781842.
BUILT-IN TEMPERATURE MONITORING
K801240 · Bentley Laboratories, Inc. · Jun 1980
WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
K792039 · C.R. Bard, Inc. · Oct 1979
OXYGENATOR, COBE CATALOG #42-220
K790356 · Cobe Laboratories, Inc. · Mar 1979
OXYGENATOR, BUBBLE TYPE
K780078 · Bentley Laboratories, Inc. · Sep 1978
OXYGENATOR, BLOOD, INFANT/PEDIATRIC
K781223 · Shiley, Inc. · Jul 1978
BUBBLE-TYPE OXYGENATOR
K772284 · Cobe Laboratories, Inc. · Feb 1978