EnSite X EP System
FDA 510(k) K212061 · Abbott
510(k) numberK212061
Submission
- Device name
- EnSite X EP System
- Applicant
- Abbott
St. Paul, MN, US - Received
- July 1, 2021
- Decision date
- October 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | 07/02/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | 04/24/2026SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | 09/17/2025SE |
| K233655 | Lingo Glucose SystemSAF · Traditional | 05/29/2024SE |
| K222297 | CentriMag Pre-connected PackDTZ · Traditional | 12/01/2022SE |
| K221213 | EnSite X EP SystemDQK · Traditional | 08/18/2022SE |
| K210392 | WorkMate Claris SystemDQK · Special | 03/11/2021SE |
| K192593 | Confirm Rx Insertable Cardiac MonitorMXC · Special | 10/18/2019SE |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | 05/29/2019SE |
| K182981 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | 03/29/2019SE |
Questions and answers
When was EnSite X EP System cleared by the FDA?
EnSite X EP System (K212061) received a 510(k) decision of Substantially Equivalent on October 22, 2021, 113 days after the submission was received.
What is the product code of K212061?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.