Cleared Traditional

K882758 - CENTRIFUGAL PUMP SYSTEM LX/DX VERSION

K882758 is the FDA 510(k) clearance for CENTRIFUGAL PUMP SYSTEM LX/DX VERSION by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K882758 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
100d
Days
Class 2
Risk

K882758 is an FDA 510(k) clearance for the CENTRIFUGAL PUMP SYSTEM LX/DX VERSION. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on October 13, 1988 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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 K882758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1988
Decision Date October 13, 1988
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 42
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K882758.
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · 3M Company · Jul 1990
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
K900601 · 3M Company · Mar 1990
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659 · 3M Health Care, Sarns · Jan 1989
ELECATH PULSATILE PERFUSION PUMP
K854975 · Electro-Catheter Corp. · Jan 1986
MODEL 1861 BLOOD PUMP
K780953 · Medtronic Vascular · Aug 1978