Cleared Traditional

K041693 - WRIST DIGITAL BLOOD PRESSURE MONITOR (D...

K041693 is the FDA 510(k) clearance for WRIST DIGITAL BLOOD PRESSURE MONITOR (D... by Hangzhou Hua'An Medical & Health Instruments Co.,. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K041693 · Hangzhou Hua'An Medical & Health Instruments Co., · Cardiovascular device
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Dec 2004
Decision
163d
Days
Class 2
Risk

K041693 is an FDA 510(k) clearance for the WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Hangzhou Hua'An Medical & Health Instruments Co., (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on December 2, 2004 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Hangzhou Hua'An Medical & Health Instruments Co., devices

Submission Details

510(k) Number K041693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2004
Decision Date December 02, 2004
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 509
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K041693.
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · Health & Life Co., Ltd. · Jan 2005
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
K043186 · Health & Life Co., Ltd. · Dec 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
K042967 · A&D Engineering, Inc. · Dec 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA
K042853 · Health & Life Co., Ltd. · Nov 2004
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
K043018 · Omron Healthcare, Inc. · Nov 2004
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q
K042802 · Health & Life Co., Ltd. · Oct 2004