Cleared Traditional

K853516 - SARNS RETROGRADE CARDIOPLEGIA DELIVERY ...

K853516 is the FDA 510(k) clearance for SARNS RETROGRADE CARDIOPLEGIA DELIVERY ... by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K853516 · 3M Health Care, Sarns · Cardiovascular device
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Nov 1985
Decision
84d
Days
Class 2
Risk

K853516 is an FDA 510(k) clearance for the SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 K853516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1985
Decision Date November 14, 1985
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 78
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K853516.
CPS-3000 CARDIOPLEGIA RESERVOIR
K861102 · Gish Biomedical, Inc. · May 1986
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · Shiley, Inc. · May 1986
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
K853791 · Norton Performance Plastics Corp. · Dec 1985
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · Intermedics, Inc. · Oct 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · Shiley, Inc. · Sep 1985
PATIENT MONITOR MODEL RM-300
K850794 · Honeywell, Inc. · Apr 1985