Cleared Special

K012310 - MODIFICATION TO:HL168D BLOOD PRESSURE M...

K012310 is an FDA 510(k) clearance for MODIFICATION TO:HL168D BLOOD PRESSURE M..., 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 30-day FDA review.

K012310 · Health & Life Co., Ltd. · Cardiovascular device
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Aug 2001
Decision
30d
Days
Class 2
Risk

K012310 is an FDA 510(k) clearance for the MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Health & Life Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on August 22, 2001 after a review of 30 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 - K012310

510(k) Number K012310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date August 22, 2001
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K012310.
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
K012472 · A&D Engineering, Inc. · Feb 2002
HL168E
K014122 · Health & Life Co., Ltd. · Jan 2002
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · Health & Life Co., Ltd. · Oct 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · A&D Engineering, Inc. · Jul 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · Welch Allyn, Inc. · Jun 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · A&D Engineering, Inc. · Mar 2001