Cleared Traditional

K110922 - PATIENT MONITOR

K110922 is the FDA 510(k) clearance for PATIENT MONITOR by Edan Instruments, Inc.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K110922 · Edan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
110d
Days
Class 2
Risk

K110922 is an FDA 510(k) clearance for the PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on July 20, 2011 after a review of 110 days - within the typical 510(k) review window.

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 Edan Instruments, Inc. devices

Submission Details

510(k) Number K110922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date July 20, 2011
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 256
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K110922.
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
K113798 · Draeger Medical Systems, Inc. · Mar 2012
PATIENT MONITOR
K113653 · Edan Instruments, Inc. · Feb 2012
PATIENT MONITOR
K113623 · Edan Instruments, Inc. · Feb 2012
FUKUDA DENSHI
K103134 · Fukuda Denshi USA, Inc. · Mar 2011
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
K102495 · Philips Medical Systems · Sep 2010
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2010