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FDA 510(k)

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

K-Number: K253196 · 2026-06-12

ApplicantMidmark Corporation
Decision Date2026-06-12
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253196. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Midmark Corporation. The 510(k) number is K253196.

When did Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) receive FDA 510(k) clearance?

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253196.

Who is the listed applicant for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

The FDA 510(k) record lists Midmark Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

The FDA product code for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is MWI.

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Other records listing Midmark Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251626Midmark Dental Delivery SystemK233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerK201667Midmark Extraoral Imaging System (EOIS)K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerK161909IQvitals Zone

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BVK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.K241958WARD-CSS (v1.2.x)Ward 24/7 ApsK243146iCare APPIhealth Labs, Inc.

Official Source

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