Cleared Special

K043186 - H & L (NIBP) BLOOD PRESSURE MONITOR

K043186 is an FDA 510(k) clearance for H & L (NIBP) BLOOD PRESSURE MONITOR, manufactured by Health & Life Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 19-day FDA review.

K043186 · Health & Life Co., Ltd. · Cardiovascular device
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Dec 2004
Decision
19d
Days
Class 2
Risk

K043186 is an FDA 510(k) clearance for the H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Health & Life Co., Ltd. (Chung Ho City, Taipei, Hsien, TW). The FDA issued a Cleared decision on December 6, 2004 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Health & Life Co., Ltd. devices

FDA 510(k) Submission Details - K043186

510(k) Number K043186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2004
Decision Date December 06, 2004
Days to Decision 19 days
Submission Type Special
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
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K043186.
HL168JP
K050249 · Health & Life Co., Ltd. · Mar 2005
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K043217 · A&D Engineering, Inc. · Mar 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · Health & Life Co., Ltd. · Jan 2005
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