Cleared Traditional

K780078 - OXYGENATOR

K780078 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 240-day FDA review.

K780078 · Bentley Laboratories, Inc. · Cardiovascular device
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Sep 1978
Decision
240d
Days
Class 2
Risk

K780078 is an FDA 510(k) clearance for the OXYGENATOR, BUBBLE TYPE. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978 after a review of 240 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K780078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1978
Decision Date September 14, 1978
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
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 K780078.
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, BLOOD BOS-10
K781842 · Bentley Laboratories, Inc. · Nov 1978
OXYGENATOR, BLOOD, INFANT/PEDIATRIC
K781223 · Shiley, Inc. · Jul 1978
BUBBLE-TYPE OXYGENATOR
K772284 · Cobe Laboratories, Inc. · Feb 1978
OXYGENATOR, BUBBLE
K772237 · Shiley, Inc. · Dec 1977