Cleared Traditional

K921550 - LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODE...

K921550 is an FDA 510(k) clearance for LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODE..., manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K921550 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
58d
Days
Class 2
Risk

K921550 is an FDA 510(k) clearance for the LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Chelmsford, US). The FDA issued a Cleared decision on May 21, 1992 after a review of 58 days - a notably fast clearance cycle.

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: 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 St. Jude Medical, Inc. devices

FDA 510(k) Submission Details - K921550

510(k) Number K921550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date May 21, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFM Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K921550.
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
K933014 · St. Jude Medical, Inc. · Sep 1994
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547 · 3M Health Care, Sarns · Sep 1993
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363 · 3M Health Care, Ltd. · Jul 1993
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · 3M Health Care, Sarns · Nov 1991
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · 3M Company · Dec 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · 3M Company · Jul 1990