Cleared Traditional

K250854 - Multi-parameter Patient Monitor (N10)

Also marketed or referenced as:
Multi-parameter Patient Monitor (N12) Multi-parameter Patient Monitor (N15) Multi-parameter Patient Monitor (N10MPro) Multi-parameter Patient Monitor (N12MPro) Multi-parameter Patient Monitor (N15MPro)

K250854 is an FDA 510(k) clearance for Multi-parameter Patient Monitor (N10), manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
271d
Days
Class 2
Risk

K250854 is an FDA 510(k) clearance for the Multi-parameter Patient Monitor (N10). Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Shenzhen Comen Medical Instruments Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on December 17, 2025 after a review of 271 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Shenzhen Comen Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K250854

510(k) Number K250854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2025
Decision Date December 17, 2025
Days to Decision 271 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
146d slower than avg
Panel avg: 125d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
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