Cleared Special

K032913 - HL888 AF

K032913 is an FDA 510(k) clearance for HL888 AF, 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.

K032913 · Health & Life Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
30d
Days
Class 2
Risk

K032913 is an FDA 510(k) clearance for the HL888 AF. 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 October 2, 2003 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 - K032913

510(k) Number K032913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date October 02, 2003
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 K032913.
HL888BA
K032839 · Health & Life Co., Ltd. · Oct 2003
MODIFICATION TO HL168
K033043 · Health & Life Co., Ltd. · Oct 2003
HL888BF
K032695 · Health & Life Co., Ltd. · Oct 2003
BLOOD PRESSURE MONITOR, MODEL KP-7000
K032492 · K-Jump Health Co., Ltd. · Sep 2003
HL168R
K031695 · Health & Life Co., Ltd. · Jul 2003
HL888RA
K031835 · Health & Life Co., Ltd. · Jul 2003