Cleared Traditional

K183623 - LifeSPARC Pump, LifeSPARC Controller

K183623 is an FDA 510(k) clearance for LifeSPARC Pump, manufactured by Cardiacassist, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K183623 · Cardiacassist, Inc. · Cardiovascular device
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Jul 2019
Decision
195d
Days
Class 2
Risk

K183623 is an FDA 510(k) clearance for the LifeSPARC Pump, LifeSPARC Controller. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 9, 2019 after a review of 195 days - an extended review 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: 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 Cardiacassist, Inc. devices

FDA 510(k) Submission Details - K183623

510(k) Number K183623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date July 09, 2019
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 68
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K183623.
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