Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
FDA 510(k) K253196 · Midmark Corporation
510(k) numberK253196
Submission
- Device name
- Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
- Applicant
- Midmark Corporation
Versailles, OH, US - Received
- September 26, 2025
- Decision date
- June 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)MWI · Traditional | Analog Devices | 12/10/2024SE |
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| K201667 | Midmark Extraoral Imaging System (EOIS)OAS · Traditional | 08/06/2020SE |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D…FLE · Traditional | 08/31/2017SE |
| K161909 | IQvitals ZoneMWI · Traditional | 11/17/2016SE |
| K122643 | Vantage Model V5000, V5100, V5000C, V5100CMUH · Traditional | 01/07/2013SE |
| K120239 | ElevanceEIA · Special | 08/24/2012SE |
| K112380 | ClearvisionMUH · Traditional | 11/22/2011SE |
| K091866 | Progeny Vantage Panoramic X-Ray SystemMUH · Traditional | 07/20/2009SE |
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Questions and answers
When was Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) cleared by the FDA?
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (K253196) received a 510(k) decision of Substantially Equivalent on June 12, 2026, 259 days after the submission was received.
What is the product code of K253196?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.