Cleared Traditional

K915183 - SARNS 8000 MODULAR PERFUSION SYSTEM

K915183 is an FDA 510(k) clearance for SARNS 8000 MODULAR PERFUSION SYSTEM, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K915183 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
233d
Days
Class 2
Risk

K915183 is an FDA 510(k) clearance for the SARNS 8000 MODULAR PERFUSION SYSTEM. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on July 8, 1992 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K915183

510(k) Number K915183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date July 08, 1992
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 26
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K915183.
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
SARNS 9000 HEART-LUNG CONSOLE
K871131 · 3M Health Care, Sarns · May 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976 · Cobe Laboratories, Inc. · May 1987
STOCKERT-SHILEY CAPS BATTERY MODULE
K863960 · Shiley, Inc. · Dec 1986