Cleared Traditional

K043550 - AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100

K043550 is an FDA 510(k) clearance for AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, manufactured by Amplife Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K043550 · Amplife Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
35d
Days
Class 2
Risk

K043550 is an FDA 510(k) clearance for the AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Amplife Corporation (Great Neck, US). The FDA issued a Cleared decision on January 27, 2005 after a review of 35 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.

FDA 510(k) Submission Details - K043550

510(k) Number K043550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2004
Decision Date January 27, 2005
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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

Entela, Inc.

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 1143
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K043550.
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
K043217 · A&D Engineering, Inc. · Mar 2005
MEDICOMPASS CONNECT
K042768 · Imetrikus, Inc. · Feb 2005
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
K042818 · Matsushita Electric Works, Ltd. · Jan 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · Health & Life Co., Ltd. · Jan 2005
VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
K032825 · Mars Medical Products Co., Ltd. · Dec 2004
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
K043186 · Health & Life Co., Ltd. · Dec 2004
K043550 · AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
Download PDF FDA Summary Amplife Corporation