Cleared Traditional

K221491 - Anivia SG1000 Pump Console

K221491 is an FDA 510(k) clearance for Anivia SG1000 Pump Console, manufactured by Apmtd, Inc.. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K221491 · Apmtd, Inc. · Cardiovascular device
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Feb 2023
Decision
256d
Days
Class 2
Risk

K221491 is an FDA 510(k) clearance for the Anivia SG1000 Pump Console. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Apmtd, Inc. (Wilmington, US). The FDA issued a Cleared decision on February 3, 2023 after a review of 256 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - 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 Apmtd, Inc. devices

FDA 510(k) Submission Details - K221491

510(k) Number K221491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2022
Decision Date February 03, 2023
Days to Decision 256 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
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWA Device Classification - Class 2, Special Controls

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 13
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K221491.
INSPIRA ART100
K232788 · Inspira Technologies Oxy B.H.N. , Ltd. · May 2024
Anivia SG1000 Pump Console
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Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
K192838 · Spectrum Medical , Ltd. · Apr 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
K200306 · Abbott (Formerly Thoratec Corporation) · Mar 2020
CentriMag Acute Circulatory Support System
K191557 · Thoratec Corporation (Now Part of Abbott) · Jul 2019
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · Medtronic, Inc. · Jul 2013