Cleared Traditional

K092163 - FULL AUTOMATIC (NIBP) BLOOD PRESSURE MO...

K092163 is an FDA 510(k) clearance for FULL AUTOMATIC (NIBP) BLOOD PRESSURE MO..., manufactured by Health & Life Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K092163 · Health & Life Co., Ltd. · Cardiovascular device
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Nov 2009
Decision
123d
Days
Class 2
Risk

K092163 is an FDA 510(k) clearance for the FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB. 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 November 16, 2009 after a review of 123 days - within the typical 510(k) review window.

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 Health & Life Co., Ltd. devices

FDA 510(k) Submission Details - K092163

510(k) Number K092163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2009
Decision Date November 16, 2009
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Center For Measurement Standards of Industrial
TZU-WEI LI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 565
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