Cleared Traditional

K062033 - BP 101 DIGITAL BLOOD PRESSURE MONITOR

K062033 is an FDA 510(k) clearance for BP 101 DIGITAL BLOOD PRESSURE MONITOR, manufactured by Kingyield Hongkong Limited. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K062033 · Kingyield Hongkong Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
248d
Days
Class 2
Risk

K062033 is an FDA 510(k) clearance for the BP 101 DIGITAL BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Kingyield Hongkong Limited (North Point, HK). The FDA issued a Cleared decision on March 23, 2007 after a review of 248 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Kingyield Hongkong Limited devices

FDA 510(k) Submission Details - K062033

510(k) Number K062033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2006
Decision Date March 23, 2007
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 125d · This submission: 248d
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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 896
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K062033.
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
K070086 · Sensacare , Ltd. · May 2007
247 BP DEVICE
K070750 · Suntech Medical, Inc. · May 2007
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000
K063137 · Pharmasmart, Inc. · May 2007
BP-200 PLUS
K063814 · Schiller AG · Mar 2007
KODEA, MODELS XJ-2001AC
K062893 · Shanghai Kodea Economic and Trade Development , Ltd. · Feb 2007
FINOMETER MODEL-2 WITH ACCESSORIES
K063111 · Finapres Medical Systems B.V. · Feb 2007