EndoPATx— 510(k) K211557

Name: FDA 510(k) clearance K211557
Creator: U.S. Food and Drug Administration
Published: 2022-12-29

Substantially Equivalent

Itamar Medical , Ltd.

FDA 510(k) clearance K211557 for EndoPATx, Substantially Equivalent on 2022-12-29. Applicant: Itamar Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Itamar Medical , Ltd.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2021-05-19
Decision date: 2022-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

view all

K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

More clearances from Itamar Medical , Ltd.

view all

K254042 — WatchPAT SW2026-07-31
K250460 — WatchPAT400 (WP400)2025-09-05
K223675 — WatchPAT ONE (WP1)2023-01-06
K222331 — WatchPAT300 (WP300)2022-09-14
K203839 — WatchPAT200U (WP200U)2022-03-21

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.