WARD-CSS (v1.2.x)
FDA 510(k) clearance K241958 · decided 2025-02-14
Clearance details
- K-number
- K241958
- Device name
- WARD-CSS (v1.2.x)
- Applicant
- Ward 24/7 Aps
- Decision
- Substantially Equivalent
- Date received
- 2024-07-03
- Decision date
- 2025-02-14
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Copenhagen, DK
- 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.
| Record | Firm | Date |
|---|---|---|
| Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (K253196) | Midmark Corporation | 2026-06-12 |
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| WAVE Clinical Platform (2.0.000) (K250135) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766) | Fysicon BV | 2025-08-27 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K242737) | Empatica S.r.l. | 2025-06-06 |
| iCare APP (K243146) | Ihealth Labs, Inc. | 2025-02-03 |
| Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (K241411) | Welch Allyn, Inc. | 2024-12-20 |
| Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (K243216) | Analog Devices | 2024-12-10 |
| AMC Health CareConsole (K233446) | Amc Health | 2024-09-27 |
| Happy Ring Health Monitoring System (K240236) | Happy Health, Inc. | 2024-09-24 |
| WVSM Pro (Series) (500-0030-XX) (K233354) | Athena Gtx, Inc. | 2024-06-26 |
| NeoBeat, NeoBeat Mini (K232111) | Laerdal Medical AS | 2024-06-25 |
Recalls involving this device
No recalls on record reference this clearance.