Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQK — Predicate Candidate Screening
435 FDA 510(k) clearances under this product code; the 50 most recent screened below.
103 daysmedian FDA review time
272 days90th percentile
435clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 | 251 | 0 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 | 30 | 0 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 | 295 | 0 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 | 267 | 0 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 | 88 | 0 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 | 262 | 0 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpo | Centerline Biomedical | 2026-06-10 | 49 | 0 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 | 262 | 0 |
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 | 87 | 0 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 | 131 | 0 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 | 173 | 0 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 | 151 | 0 |
| K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 | 156 | 0 |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Ca | Centerline Biomedical, Inc. | 2026-02-17 | 60 | 0 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 | 262 | 0 |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 | 291 | 0 |
| K252164 | NorthStar™ Mapping System | Imricor Medical Systems | 2026-01-28 | 202 | 0 |
| K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 | 31 | 0 |
| K253733 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 2025-12-19 | 25 | 0 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTA | Edwards Lifesciences | 2025-12-18 | 128 | 0 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 | 77 | 0 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 | 125 | 0 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025-10-24 | 64 | 0 |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025-10-24 | 99 | 0 |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025-10-21 | 29 | 0 |
| K252013 | EnSite™ X EP System | ABBOTT MEDICAL | 2025-09-25 | 90 | 0 |
| K251518 | Volta AF-Xplorer II | Volta Medical | 2025-09-12 | 119 | 0 |
| K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE | ABBOTT MEDICAL | 2025-09-04 | 115 | 0 |
| K252302 | CARTO™ 3 EP Navigation System V8.1 | Biosense Webster, Inc. | 2025-08-22 | 29 | 0 |
| K251234 | EnSite™ X EP System | ABBOTT MEDICAL | 2025-07-30 | 99 | 0 |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Mo | Edwards Lifesciences | 2025-07-23 | 226 | 0 |
| K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025-06-25 | 105 | 0 |
| K250749 | PhysCade System | Physcade, Inc. | 2025-06-04 | 84 | 0 |
| K251344 | OptiMap™ System | Boston Scientific Corporation | 2025-05-28 | 28 | 0 |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-05-27 | 60 | 0 |
| K243812 | Volta AF-Xplorer | Volta Medical | 2025-05-09 | 149 | 0 |
| K242129 | VitalRhythm | Vitalconnect, Inc. | 2025-04-17 | 269 | 0 |
| K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025-03-06 | 83 | 1 |
| K243312 | CER-S | Cardiocalm Srl | 2025-02-20 | 121 | 0 |
| K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025-01-17 | 30 | 0 |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (Alti | Ge Medical Systems Information Technologies, Inc. | 2024-12-12 | 27 | 0 |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024-12-05 | 30 | 0 |
| K241197 | DeepRhythmAI | Medicalgorithmics S.A. | 2024-12-04 | 218 | 0 |
| K241828 | Affera Integrated Mapping System; Impedance Localization Pat | Medtronic, Inc. | 2024-11-01 | 130 | 0 |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Trackin | Centerline Biomedical, Inc. | 2024-10-11 | 81 | 1 |
| K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | 2024-08-29 | 119 | 0 |
| K233755 | HeartKey® Rhythm | B-Secur Limited | 2024-08-16 | 268 | 0 |
| K242016 | EnSite™ X EP System | ABBOTT MEDICAL | 2024-08-09 | 30 | 0 |
| K240509 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 2024-07-26 | 155 | 0 |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple | Centerline Biomedical, Inc. | 2024-07-24 | 82 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda