# Abbott (St. Jude Medical)

- Location (FDA's records): Sylmar, CA
- FDA decisions: 6 (2019–2021): 6 510(k) clearances
- Product codes: MXC (5), DQY (1)
- 510(k) review time since 2016: median 64 days, against 64 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 5 (3 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
- Abbott: 1 (https://510kreport.com/company/abbott)
- Medtronic Inc. Cardiac Rhythm Management: 1 (https://510kreport.com/company/medtronic-cardiac-rhythm-management)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)

## Firms that cite its devices most
- Abbott: 1 (https://510kreport.com/company/abbott)
- Abbott Medical: 1 (https://510kreport.com/company/abbott-medical)

## Its most-cited devices
- K193310: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (2020), cited by 2
- K190295: Confirm Rx Insertable Cardiac Monitor (2019), cited by 1
- K212206: Jot Dx Insertable Cardiac Monitor (2021), cited by 1
- K202888: Confirm Rx Insertable Cardiac Monitor (2020), cited by 1

## Recent decisions
- K212206: Jot Dx Insertable Cardiac Monitor (Aug 13, 2021)
- K202876: Confirm Rx Insertable Cardiac Monitor (Dec 1, 2020)
- K202888: Confirm Rx Insertable Cardiac Monitor (Nov 23, 2020)
- K200721: Agilis HisPro Steerable Catheter With Electrodes (Jun 3, 2020)
- K193310: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (Mar 17, 2020)
- K190295: Confirm Rx Insertable Cardiac Monitor (Apr 10, 2019)

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