Cleared Special

K002750 - HL168T (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002750 · Health & Life Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
13d
Days
Class 2
Risk

K002750 is an FDA 510(k) clearance for the HL168T. 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 September 18, 2000 after a review of 13 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

Submission Details

510(k) Number K002750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date September 18, 2000
Days to Decision 13 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1209
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K002750.
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
K260260 · Honsun (Nantong) Co., Ltd. · Apr 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
K252501 · Joytech Healthcare Co. , Ltd. · Apr 2026
Korotkoff sound blood pressure monitor
K253982 · Beijing Hanvon Health Technology Co., Ltd. · Apr 2026
Arm Blood Pressure Monitor Models: ARM-30C+
K260276 · Shenzhen AOJ Medical Technology Co., Ltd. · Apr 2026
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
K254225 · Shenzhen HanHan Technology Co., Ltd. · Apr 2026
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
K260273 · Shenzhen Urion Technology Co., Ltd. · Mar 2026