Cleared Traditional

K211830 - LifeSPARC System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211830 · Cardiacassist, Inc. · Cardiovascular device
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Nov 2022
Decision
519d
Days
Class 2
Risk

K211830 is an FDA 510(k) clearance for the LifeSPARC System. Classified as Blood Pump For Ecmo, Long-term (> 6 Hours) Use (product code QNR), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on November 15, 2022 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cardiacassist, Inc. devices

Submission Details

510(k) Number K211830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2021
Decision Date November 15, 2022
Days to Decision 519 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
394d slower than avg
Panel avg: 125d · This submission: 519d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNR Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
Definition A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
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.