Cleared Traditional

K041693 - WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES

K041693 is an FDA 510(k) clearance for WRIST DIGITAL BLOOD PRESSURE MONITOR (D..., manufactured by Hangzhou Hua'An Medical & Health Instruments Co.,. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K041693

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
Combination Product No
PCCP Authorized No
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.

DXN Device Classification - Class 2, Special Controls

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 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K041693.
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COMMANDER II
K043096 · Cardiocom · Nov 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