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FDA 510(k)

ILR ECG Analyzer (IM007)

K-Number: K253463 · 2026-07-02

ApplicantImplicity, Inc.
Decision Date2026-07-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ILR ECG Analyzer (IM007) is the device name listed in this FDA 510(k) record. The listed applicant is Implicity, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K253463. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILR ECG Analyzer (IM007)?

ILR ECG Analyzer (IM007) is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Implicity, Inc.. The 510(k) number is K253463.

When did ILR ECG Analyzer (IM007) receive FDA 510(k) clearance?

ILR ECG Analyzer (IM007) received FDA 510(k) clearance on 2026-07-02, under 510(k) number K253463.

Who is the listed applicant for ILR ECG Analyzer (IM007)?

The FDA 510(k) record lists Implicity, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ILR ECG Analyzer (IM007)?

The FDA product code for ILR ECG Analyzer (IM007) is DQK.

Other records listing Implicity, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230842SignalHF (IM008)K210543IM007

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)Centerline Biomedical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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