Cleared Traditional

K953901 - SARNS 800 ROLLER PUMP

K953901 is the FDA 510(k) clearance for SARNS 800 ROLLER PUMP by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DWB) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K953901 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
245d
Days
Class 2
Risk

K953901 is an FDA 510(k) clearance for the SARNS 800 ROLLER PUMP. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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

Submission Details

510(k) Number K953901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1995
Decision Date April 19, 1996
Days to Decision 245 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
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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 - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 7
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K953901.
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904 · Shiley, Inc. · Apr 1989
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · Shiley, Inc. · Jul 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · Shiley, Inc. · Jul 1986
SARNS PULSATILE PUMP
K820729 · 3M Health Care, Sarns · Nov 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071 · Gambro, Inc. · Aug 1982
COBE/STOCKERT BATTERY MODULE
K802714 · Cobe Laboratories, Inc. · Nov 1980