FlowSaver Blood Filter— 510(k) K210176

Clearance details

Applicant

Inari Medical

Product code

Code CAC

Device class

Class 2

Regulation

21 CFR 868.5830

Advisory panel

Anesthesiology

Date received

2021-01-22

Decision date

2021-07-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

• K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
• K240426 — Aventus Clot Management System2024-05-14
• K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
• K231782 — FlowSaver Blood Return System (80-101)2023-07-14
• K221483 — FlowSaver Blood Return System2023-02-17

• K253323 — Protrieve Sheath2025-10-29
• K230912 — Artix BG2023-05-02
• K223419 — Triever16 Curve2023-03-23
• K223436 — Artix AX2023-03-02
• K223000 — Artix BG2023-01-11

Death

11

Malfunction

477

Total

488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →