HemoSphere Advanced Monitor (HEM1) +9 more— 510(k) K243781

Clearance details

Device name as filed

HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

Applicant

Edwards Lifesciences

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2024-12-09

Decision date

2025-07-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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

• K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (4 models)2026-06-26
• K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts2026-06-05
• K254279 — Edwards eSheath+ introducer set2026-04-17
• K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)2025-12-18
• K253034 — HemoSphere Stream Module2025-10-21

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 →