Atlas FDA

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote

FDA 510(k) clearance K213682 · decided 2022-06-22

Clearance details

K-number
K213682
Device name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
Applicant
Edwards Lifesciences, LLC
Decision
Substantially Equivalent
Date received
2021-11-22
Decision date
2022-06-22
Days to decision
212 days
Clearance type
Traditional
Product code
DQK
Device class
2
Regulation number
870.1425
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CorVista System® with PCWP Add-On (K253576)Analytics For Life, Inc.2026-07-26
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ScioCardio ECG Analysis Platform (K252978)Synergen Technology Labs, LLC2026-07-09
ILR ECG Analyzer (IM007) (K253463)Implicity, Inc.2026-07-02
NorthStar Mapping System (MAP01 or MAP01-01) (K261119)Imricor Medical Systems, Inc.2026-06-30
OneStim-DUO Cardiac Stimulator (MP5003-4CO) (K253088)Micropace Pty, Ltd.2026-06-12
Intra-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) (K261329)Centerline Biomedical2026-06-10
ZEUS Platform (FG0501US) (K252859)iRhythm Technologies, Inc.2026-05-29
EnSite™ X EP System (K260212)ABBOTT MEDICAL2026-04-20
ACORYS MAPPING SYSTEM (K253861)Corify Care S.L2026-04-13
Synchrony (K253473)Stereotaxis, Inc.2026-04-01
HemoSphere Nano Monitor (HSNANO1) (K253186)Edwards Lifesciences, LLC2026-02-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S032)Edwards Lifesciences, LLC2026-08-05
PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS) (P220003/S031)Edwards Lifesciences, LLC2026-07-29
EDWARDS INTUITY Elite Valve, Model 8300AB (P150036/S080)Edwards Lifesciences, LLC2026-07-29
Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis Model 2800; Carpentier-Edwards PERIMOUNT RSR Pericardi (P860057/S227)Edwards Lifesciences, LLC2026-07-29
EINSPIRIS RESILIA Aortic Valve, Model 11500A; KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A (P150048/S103)Edwards Lifesciences, LLC2026-07-29
Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR); Edwards Commande (P250019/S006)Edwards Lifesciences, LLC2026-07-29
EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK) (P230013/S031)Edwards Lifesciences, LLC2026-07-29
Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29); (P140031/S208)Edwards Lifesciences, LLC2026-07-29