Cleared Traditional

K061557 - FUSION

K061557 is an FDA 510(k) clearance for FUSION, manufactured by Medwave, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K061557 · Medwave, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
102d
Days
Class 2
Risk

K061557 is an FDA 510(k) clearance for the FUSION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Medwave, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 102 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K061557

510(k) Number K061557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date September 15, 2006
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1225
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K061557.
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
K062027 · A&D Engineering, Inc. · Jan 2007
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
K061935 · Sensacare , Ltd. · Nov 2006
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
K062462 · Jawon Medical Co., Ltd. · Sep 2006
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
K061471 · Microlife Intellectual Property GmbH · Sep 2006
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
K061959 · Mytech Technology Co., Ltd. · Aug 2006
LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K061279 · Little Doctor (Shanghai) Electronic · Aug 2006
K061557 · FUSION
Download PDF FDA Summary Medwave, Inc.