# Abbott Medical

- Location (FDA's records): St. Paul, MN
- FDA decisions: 92 (1982–2026): 60 510(k) clearances and 32 original PMA approvals
- Names in FDA's records: ABBOTT MEDICAL (89); Abbott Medical (3)
- Product codes: DQK (14), DQY (13), DYB (4), MLV (3), OWQ (3), NQQ (3), DQO (3), DQX (3), DSQ (2), LWS (2), GXD (2), OBJ (2)
- 510(k) review time since 2016: median 58 days, against 108 for FDA's reviews in the same codes and years (35 of 49 faster)
- Predicates its devices cite: 78 (30 its own); citations of its devices by later devices: 52 (30 its own)
- Recalls linked to its devices: 146 (35 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 14 (https://510kreport.com/company/st-jude-medical)
- Abbott: 6 (https://510kreport.com/company/abbott)
- Irvine Biomedical, A St. Jude Medical Company: 3 (https://510kreport.com/company/irvine-biomedical-a-st-jude-medical)
- St. Jude Medical (Now Abbott Medical): 3 (https://510kreport.com/company/st-jude-medical-now-abbott-medical)
- Abbott Vascular: 2 (https://510kreport.com/company/abbott-vascular)
- Merit Medical Systems, Inc.: 2 (https://510kreport.com/company/merit-medical-systems)
- Abbott (Formerly Thoratec Corporation): 2 (https://510kreport.com/company/abbott-formerly-thoratec)
- Lightlab Imaging, Inc.: 2 (https://510kreport.com/company/lightlab-imaging)

## Firms that cite its devices most
- St. Jude Medical, Cardiac Rhythm Management Divisi: 6 (https://510kreport.com/company/st-jude-medical-cardiac-rhythm-management-divisi)
- St Jude Medical: 5 (https://510kreport.com/company/st-jude-medical)
- Abbott: 3 (https://510kreport.com/company/abbott)
- Innovative Health, LLC: 1 (https://510kreport.com/company/innovative-health)
- Shenzhen Vivolight Medical Device & Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-vivolight-medical-device-technology)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Surgical Instrument Service and Savings, Inc.: 1 (https://510kreport.com/company/surgical-instrument-service-and-savings)
- Spectrawave, Inc.: 1 (https://510kreport.com/company/spectrawave)

## Its most-cited devices
- P030054: ST Jude Medical Epic HF System (2004), cited by 4
- K242016: EnSite™ X EP System (2024), cited by 4
- P950022: TVL (TM) Lead System (1996), cited by 3
- K192019: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (2019), cited by 3
- K210458: OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (2021), cited by 2
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), cited by 2

## Recent decisions
- K261729: EnSite™ X EP System (Sep 17, 2026)
- K262006: EnSite™ X EP System (Jul 15, 2026)
- K261631: Amplatzer TorqVue Exchange System (Jun 17, 2026)
- K253459: OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (Apr 24, 2026)
- K260212: EnSite™ X EP System (Apr 20, 2026)
- K253907: Disposable Radiofrequency Cannula (Apr 16, 2026)
- K260499: Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (Mar 13, 2026)
- K252512: Armada™ 14 NC PTA Catheter (Feb 13, 2026)

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