# St Jude Medical

- Location (FDA's records): Minnetonka, MN
- FDA decisions: 139 (1981–2018): 128 510(k) clearances and 11 original PMA approvals
- Names in FDA's records: St Jude Medical (108); St. Jude Medical, Inc. (31)
- Product codes: DYB (26), DQK (23), DRF (14), DQY (13), KRH (10), MXC (6), DQX (3), KFM (3), GZB (3), MGB (2), DXY (2), DQO (2)
- 510(k) review time since 2016: median 256 days, against 183 for FDA's reviews in the same codes and years (3 of 10 faster)
- Predicates its devices cite: 165 (85 its own); citations of its devices by later devices: 186 (85 its own)
- Recalls linked to its devices: 30 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Daig Corp.: 14 (https://510kreport.com/company/daig)
- Medtronic Vascular: 8 (https://510kreport.com/company/medtronic-vascular)
- St. Jude Medical, Cardiac Rhythm Management Divisi: 6 (https://510kreport.com/company/st-jude-medical-cardiac-rhythm-management-divisi)
- Guidant Corp.: 5 (https://510kreport.com/company/guidant)
- Velocimed, Inc.: 5 (https://510kreport.com/company/velocimed)
- Abbott Medical: 5 (https://510kreport.com/company/abbott-medical)
- Medtronic, Inc.: 4 (https://510kreport.com/company/medtronic)
- Irvine Biomedical, Inc.: 3 (https://510kreport.com/company/irvine-biomedical)

## Firms that cite its devices most
- Innovative Health, LLC: 15 (https://510kreport.com/company/innovative-health)
- Abbott Medical: 14 (https://510kreport.com/company/abbott-medical)
- Abbott: 4 (https://510kreport.com/company/abbott)
- Surgical Instrument Service and Savings, Inc.: 3 (https://510kreport.com/company/surgical-instrument-service-and-savings)
- Biotronik, Inc.: 3 (https://510kreport.com/company/biotronik)
- Stryker Sustainability Solutions: 3 (https://510kreport.com/company/stryker-sustainability-solutions)
- Synaptic Medical Corporation: 3 (https://510kreport.com/company/synaptic-medical)
- Great Batch Medical: 2 (https://510kreport.com/company/great-batch-medical)

## Its most-cited devices
- K081645: Agilis NXT Steerable Introducer, Model G408324 (2008), cited by 16
- K061363: Agilis NXT Steerable Introducer (2006), cited by 15
- K022380: Livesire Electrophysiology Catheter (2002), cited by 8
- K002976: Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX and 401XXX (2000), cited by 7
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator (2008), cited by 6
- K151622: St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (2015), cited by 5

## Recent decisions
- K181382: GuardianTM Burr Hole Cover System (Jul 20, 2018)
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (Apr 23, 2018)
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (Apr 23, 2018)
- K173232: myMerlin (TM) Mobile Application Model APP1001 (Nov 2, 2017)
- K163407: Confirm Rx Insertable Cardiac Monitor (ICM) System (Sep 29, 2017)
- K162643: MediGuide Technology System (Dec 13, 2016)
- K160218: AutoMark Module (Dec 13, 2016)
- K160210: EnSite Precision Cardiac Mapping System v2.0 (Dec 13, 2016)

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