# Abiomed, Inc.

- Location (FDA's records): Danvers, MA
- FDA decisions: 21 (1989–2025): 19 510(k) clearances and 2 original PMA approvals
- Product codes: DYB (6), KFM (4), EIL (2), DTZ (2), DSP (2), OZD (1), PYX (1), MJN (1), PBL (1), JAO (1)
- 510(k) review time since 2016: median 71 days, against 60 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 30 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 57 (38 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arrow Intl., Inc.: 3 (https://510kreport.com/company/arrow-intl)
- Estech, Inc.: 2 (https://510kreport.com/company/estech)
- Oscor, Inc.: 2 (https://510kreport.com/company/oscor)
- Cardiacassist, Inc.: 2 (https://510kreport.com/company/cardiacassist)
- Medtronic Bio-Medicus, Inc.: 2 (https://510kreport.com/company/medtronic-bio-medicus)
- Datascope Corp.: 2 (https://510kreport.com/company/datascope)
- Endoscopic Technologies, Inc.: 1 (https://510kreport.com/company/endoscopic-technologies)
- Sorin Group Italia S.R.L.: 1 (https://510kreport.com/company/sorin-group-italia)

## Firms that cite its devices most
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)
- Abbott: 1 (https://510kreport.com/company/abbott)
- Insightra Medical: 1 (https://510kreport.com/company/insightra-medical)

## Its most-cited devices
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), cited by 3
- K200109: OXY-1 System (2020), cited by 2
- K083111: Impella 5.0 Catheter Family (2009), cited by 1
- K241708: Abiomed 14Fr Low Profile Introducer Kit (2024), cited by 1
- K093801: Impella Controller (2010), cited by 1
- K062582: Supracor Balloon Catheter (2006), cited by 1

## Recent decisions
- K252766: 14Fr Low Profile Introducer Kit (Oct 8, 2025)
- K241708: Abiomed 14Fr Low Profile Introducer Kit (Aug 6, 2024)
- K221294: preCARDIA Occlusion System (Jun 30, 2023)
- K223161: OXY-1 System (Feb 23, 2023)
- K222113: Abiomed 14Fr Low Profile Introducer Set (Oct 13, 2022)
- K202330: Impella XR Sheath Set (Dec 7, 2020)
- K200109: OXY-1 System (Oct 23, 2020)
- K201116: Abiomed 23 Fr Sheath (Jun 15, 2020)

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