Cleared Traditional

K860539 - SARNS OXYGENATOR SYSTEM

K860539 is the FDA 510(k) clearance for SARNS OXYGENATOR SYSTEM by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K860539 · 3M Health Care, Sarns · Cardiovascular device
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Apr 1986
Decision
76d
Days
Class 2
Risk

K860539 is an FDA 510(k) clearance for the SARNS OXYGENATOR SYSTEM. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on April 29, 1986 after a review of 76 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K860539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1986
Decision Date April 29, 1986
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
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 201
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K860539.
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · Scimed Life Systems, Inc. · Sep 1986
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
K860673 · American Bentley · Jun 1986
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · Terumo Medical Corp. · May 1986
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
K854045 · American Bentley · Dec 1985
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
K853251 · Johnson & Johnson Professionals, Inc. · Oct 1985
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · C.R. Bard, Inc. · Oct 1985