Cleared Traditional

K000675 - MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502

K000675 is an FDA 510(k) clearance for MANUAL DIGITAL BLOOD PRESSURE MONITOR, manufactured by Jawon Medical Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K000675 · Jawon Medical Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
15d
Days
Class 2
Risk

K000675 is an FDA 510(k) clearance for the MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Jawon Medical Co., Ltd. (Smithfield, US). The FDA issued a Cleared decision on March 14, 2000 after a review of 15 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 Jawon Medical Co., Ltd. devices

FDA 510(k) Submission Details - K000675

510(k) Number K000675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date March 14, 2000
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
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 Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 846
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K000675.
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
K991458 · Matsushita Electric Corp. of America · Apr 2000
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K994423 · Vsm Medtech , Ltd. · Mar 2000
THE HOMMED SENTRY, MODEL 1 SENTRY
K993938 · Hommed, LLC · Mar 2000
MULTIFUNCTION KEITO K5
K984083 · Bumedco Intl., Inc. · Jan 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
K993460 · Rossmax International , Ltd. · Jan 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
K993426 · Rossmax International , Ltd. · Jan 2000