Cleared Traditional

K253436 - c-med0 alpha

K253436 is an FDA 510(k) clearance for c-med0 alpha, manufactured by Cosinuss GmbH. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K253436 · Cosinuss GmbH · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
211d
Days
Class 2
Risk

K253436 is an FDA 510(k) clearance for the c-med0 alpha. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Cosinuss GmbH (Munich, DE). The FDA issued a Cleared decision on April 30, 2026 after a review of 211 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cosinuss GmbH devices

FDA 510(k) Submission Details - K253436

510(k) Number K253436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2025
Decision Date April 30, 2026
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K253436.
Vital Signs Monitor (CLEO2)
K260438 · Infinium Medical, Inc. · Aug 2026
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K253417 · Masimo Corporation · Aug 2026
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
K253196 · Midmark Corporation · Jun 2026
WAVE Clinical Platform (2.0.000)
K250135 · Baxter Healthcare Corp/ Excel Medical · Jan 2026
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · Fysicon BV · Aug 2025
Empatica Health Monitoring Platform
K242737 · Empatica S.R.L. · Jun 2025