Cleared Traditional

K014141 - DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR ...

K014141 is the FDA 510(k) clearance for DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR ... by Digibio Technology Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K014141 · Digibio Technology Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
270d
Days
Class 2
Risk

K014141 is an FDA 510(k) clearance for the DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Digibio Technology Corp. (Plano, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 270 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 Digibio Technology Corp. devices

Submission Details

510(k) Number K014141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2001
Decision Date September 13, 2002
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 517
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K014141.
HL888
K023834 · Health & Life Co., Ltd. · Jan 2003
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
K021682 · Omron Healthcare, Inc. · Dec 2002
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
K023495 · Welch Allyn, Inc. · Oct 2002
WELCH ALLYN ABPM 6100
K021756 · Welch Allyn, Inc. · Jun 2002
HL168F
K020766 · Health & Life Co., Ltd. · Apr 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
K012472 · A&D Engineering, Inc. · Feb 2002