# Abbott

- Location (FDA's records): St. Paul, MN
- FDA decisions: 14 (2018–2026): 13 510(k) clearances and 1 original PMA approval
- Product codes: DQK (5), MXC (2), DQY (2), DSQ (1), MXD (1), DRA (1), SAF (1), DTZ (1)
- 510(k) review time since 2016: median 30 days, against 95 for FDA's reviews in the same codes and years (7 of 10 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 4 (https://510kreport.com/company/st-jude-medical)
- Abbott Medical: 3 (https://510kreport.com/company/abbott-medical)
- Abbott (St. Jude Medical): 1 (https://510kreport.com/company/abbott-st-jude-medical)
- Abbott Vascular: 1 (https://510kreport.com/company/abbott-vascular)
- Abbott Diabetes Care, Inc.: 1 (https://510kreport.com/company/abbott-diabetes-care)
- Abiomed, Inc.: 1 (https://510kreport.com/company/abiomed)
- Aga Medical Corp.: 1 (https://510kreport.com/company/aga-medical)
- Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor: 1 (https://510kreport.com/company/aga-medical-wholly-owned-by-st-jude-medical-cor)

## Firms that cite its devices most
- Abbott Medical: 6 (https://510kreport.com/company/abbott-medical)
- Abbott (St. Jude Medical): 1 (https://510kreport.com/company/abbott-st-jude-medical)

## Its most-cited devices
- K183128: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), cited by 2
- K251221: Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (2025), cited by 1
- K192593: Confirm Rx Insertable Cardiac Monitor (2019), cited by 1
- K190167: MitraClip G4 Steerable Guide Catheter (2019), cited by 1
- K182644: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), cited by 1
- K221213: EnSite X EP System (2022), cited by 1

## Recent decisions
- K261825: Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (Jul 2, 2026)
- K260993: Amplatzer TorqVue Delivery System (Apr 24, 2026)
- K251221: Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (Sep 17, 2025)
- K233655: Lingo Glucose System (May 29, 2024)
- K222297: CentriMag Pre-connected Pack (Dec 1, 2022)
- K221213: EnSite X EP System (Aug 18, 2022)
- K212061: EnSite X EP System (Oct 22, 2021)
- K210392: WorkMate Claris System (Mar 11, 2021)

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