# Surmodics,Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 12 (2018–2025): 11 510(k) clearances and 1 original PMA approval
- Product codes: QEW (5), DYB (3), DQY (3), ONU (1)
- 510(k) review time since 2016: median 70 days, against 74 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 11 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- Nexgen Medical Systems, Inc.: 1 (https://510kreport.com/company/nexgen-medical-systems)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Firms that cite its devices most
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)

## Its most-cited devices
- K231022: Pounce™ Thrombectomy System (2023), cited by 2
- K220501: Pounce Thrombectomy System (2022), cited by 2
- K231828: Pounce™ Sheath (2023), cited by 1
- K192814: Pounce Thrombus Retrieval System (2020), cited by 1
- K173560: Microcatheter (2018), cited by 1
- K211492: Pounce Thrombectomy System (2021), cited by 1

## Recent decisions
- K252227: Pounce (TM) Sheath (Sep 24, 2025)
- K241362: Pounce XL Thrombectomy System (PTS-1011-7F135) (Sep 11, 2024)
- K232647: Microcatheter (Sep 29, 2023)
- K231828: Pounce™ Sheath (Sep 7, 2023)
- P210025: SurVeil Drug-Coated Balloon (Jun 16, 2023)
- K231022: Pounce™ Thrombectomy System (Jun 12, 2023)
- K221886: Sublime Microcatheter (Oct 14, 2022)
- K220501: Pounce Thrombectomy System (Mar 23, 2022)

Source page: https://510kreport.com/company/surmodics