Cleared Traditional

K210176 - FlowSaver Blood Filter

K210176 is an FDA 510(k) clearance for FlowSaver Blood Filter, manufactured by Inari Medical. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K210176

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.

CAC Device Classification - Class 2, Special Controls

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 165
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