# Inari Medical, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 58 (2015–2026): 58 510(k) clearances
- Names in FDA's records: Inari Medical, Inc. (32); Inari Medical (26)
- Product codes: QEW (49), DYB (4), CAC (3), DQY (1), PUR (1)
- 510(k) review time since 2016: median 60 days, against 65 for FDA's reviews in the same codes and years (25 of 51 faster)
- Predicates its devices cite: 63 (52 its own); citations of its devices by later devices: 67 (52 its own)
- Recalls linked to its devices: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Summit Medical, Inc.: 1 (https://510kreport.com/company/summit-medical)
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)
- Genesis Medical Interventional, Inc.: 1 (https://510kreport.com/company/genesis-medical-interventional)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Capture Vascular, Inc.: 1 (https://510kreport.com/company/capture-vascular)
- Hotspur Technologies: 1 (https://510kreport.com/company/hotspur-technologies)

## Firms that cite its devices most
- AngioDynamics, Inc.: 3 (https://510kreport.com/company/angiodynamics)
- Inquis Medical: 2 (https://510kreport.com/company/inquis-medical)
- Contego Medical, Inc.: 1 (https://510kreport.com/company/contego-medical)
- Intervene: 1 (https://510kreport.com/company/intervene)
- 880 Medical, LLC: 1 (https://510kreport.com/company/880-medical)
- Irani Medical, Inc.: 1 (https://510kreport.com/company/irani-medical)
- Innova Vascular, Inc.: 1 (https://510kreport.com/company/innova-vascular)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)

## Its most-cited devices
- K213402: Triever24, Triever20 (2022), cited by 8
- K212632: ClotTriever Thrombectomy System (2021), cited by 7
- K143563: Infusion Aspiration Catheter System (2015), cited by 7
- K191710: FlowTriever Retrieval/Aspiration System (2019), cited by 3
- K182531: ClotTriever Thrombectomy System (2018), cited by 3
- K180466: FlowTriever Retrieval/Aspiration System (2018), cited by 3

## Recent decisions
- K253419: Triever Duo Catheter (Sep 18, 2026)
- K262538: Artix™ MT;Artix™ Thin-Walled Sheath (Aug 21, 2026)
- K252508: Intri26 Introducer Sheath (Dec 17, 2025)
- K253323: Protrieve Sheath (Oct 29, 2025)
- K250421: InThrill™ Thrombectomy System (May 12, 2025)
- K250088: FlowTriever2 Catheter (Mar 13, 2025)
- K241894: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (Oct 15, 2024)
- K242557: ClotTriever XL Catheter (41-102) (Sep 27, 2024)

Source page: https://510kreport.com/company/inari-medical