Cleared Traditional

K210176 - FlowSaver Blood Filter

K210176 is the FDA 510(k) clearance for FlowSaver Blood Filter by Inari Medical. It is a Class 2 Cardiovascular device (product code CAC) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K210176 · Inari Medical · Cardiovascular device
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Jul 2021
Decision
181d
Days
Class 2
Risk

K210176 is an FDA 510(k) clearance for the FlowSaver Blood Filter. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on July 22, 2021 after a review of 181 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 868.5830 - 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 Inari Medical devices

Submission Details

510(k) Number K210176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2021
Decision Date July 22, 2021
Days to Decision 181 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
56d slower than avg
Panel avg: 125d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 - CAC Apparatus, Autotransfusion

All 117
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K210176.
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · Haemonetics Corporation · Nov 2022
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
K201305 · Atrium Medical Corporation · Sep 2021
Hemafuse System
K210862 · Sisu Global Health · Jul 2021
CATSmart, Automated Blood Processing Autotransfusion System
K210089 · Fresenius Kabi AG · Feb 2021
ProCell Surgical Sponge-Blood Recovery Unit
K193361 · Procell Surgical, Inc. · Jun 2020
CATSmart
K192368 · Fresenius Kabi AG · Sep 2019