Cleared Traditional

HL888 (K023834) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023834 · Health & Life Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
57d
Days
Class 2
Risk

K023834 is an FDA 510(k) clearance for the HL888. 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 January 14, 2003 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health & Life Co., Ltd. devices

Submission Details

510(k) Number K023834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2002
Decision Date January 14, 2003
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 270
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K023834.
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
K061073 · Taidoc Technology Corporation · Jun 2006
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
K052872 · Taidoc Technology Corporation · Nov 2005
CLEVER TD-3018A BLOOD PRESSURE MONITOR
K051703 · Taidoc Technology Corporation · Aug 2005
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · Datascope Corp. · May 1999
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · Ohmeda Medical · Aug 1994
COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD
K911310 · Ge Medical Systems Information Technologies · Jun 1991