Product code DQK: 510(k) clearances and predicates
Product code DQK covers EnSite X EP System. FDA lists 438 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
438 clearances on file under product code DQK. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 19 |
| 2023 | 21 |
| 2024 | 13 |
| 2025 | 22 |
| 2026 so far | 21 |
Recent clearances
Newest DQK clearances in the FDA index, with applicant and decision date:
- K261729, EnSite X EP System, applicant Abbott Medical, decided 2026-09-17. FDA record
- K262005, Affera Integrated Mapping System, applicant Medtronic, Inc., decided 2026-08-21. FDA record
- K253692, AVVIGO+ Multi-Modality Guidance System, applicant Boston Scientific, decided 2026-08-21. FDA record
- K253576, CorVista System® with PCWP Add-On, applicant Analytics For Life, Inc., decided 2026-07-26. FDA record
- K262006, EnSite X EP System, applicant Abbott Medical, decided 2026-07-15. FDA record
- K252978, ScioCardio ECG Analysis Platform, applicant Synergen Technology Labs, LLC, decided 2026-07-09. FDA record
- K253463, ILR ECG Analyzer (IM007), applicant Implicity, Inc., decided 2026-07-02. FDA record
- K261119, NorthStar Mapping System (MAP01 or MAP01-01), applicant Imricor Medical Systems, Inc., decided 2026-06-30. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Affera Integrated Mapping System, AVVIGO+ Multi-Modality Guidance System. Watch new DQK clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DQK?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DQK clearances include EnSite X EP System.
How many 510(k) clearances use product code DQK?
438 at the time this page was generated, from openFDA records.
How do I find a predicate device under DQK?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DQK clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.