Masimo W1
FDA 510(k) K243305 · Masimo Corporation
510(k) numberK243305
Submission
- Device name
- Masimo W1
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- October 21, 2024
- Decision date
- April 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
| K232161 | DeepRhythm PlatformDPS · Traditional | Medicalgorithmics S.A. | 06/20/2024SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
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| K253417 | Masimo Root Monitoring SystemMWI · Traditional | 08/12/2026SE |
| K260880 | SedLine Sedation MonitorOLW · Traditional | 07/10/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | 06/04/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | 07/17/2025SE |
| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
| K232512 | Masimo W1DPS · Traditional | 11/17/2023SE |
Questions and answers
When was Masimo W1 cleared by the FDA?
Masimo W1 (K243305) received a 510(k) decision of Substantially Equivalent on April 3, 2025, 164 days after the submission was received.
What is the product code of K243305?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.