Cleared Abbreviated

K011310 - NIEN MADE NON-INVASIVE BLOOD PRESSURE M...

Also marketed or referenced as:
HP-BPM0002 HP-BPM0003 HP-BPM0003-1

K011310 is the FDA 510(k) clearance for NIEN MADE NON-INVASIVE BLOOD PRESSURE M... by Nien Made Electrnics Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 81-day FDA review.

K011310 · Nien Made Electrnics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
81d
Days
Class 2
Risk

K011310 is an FDA 510(k) clearance for the NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Nien Made Electrnics Corp. (Concord, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 81 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nien Made Electrnics Corp. devices

Submission Details

510(k) Number K011310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date July 20, 2001
Days to Decision 81 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Standards-based clearance path.

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 520
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K011310.
HL168E
K014122 · Health & Life Co., Ltd. · Jan 2002
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · Health & Life Co., Ltd. · Oct 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · Health & Life Co., Ltd. · Aug 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · A&D Engineering, Inc. · Jul 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · Welch Allyn, Inc. · Jun 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · A&D Engineering, Inc. · Mar 2001