Cleared Traditional

K060194 - MARCH HEALTHCARE HEALTH MONITORING KIT

K060194 is an FDA 510(k) clearance for MARCH HEALTHCARE HEALTH MONITORING KIT, manufactured by March Healthcare Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K060194 · March Healthcare Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
19d
Days
Class 2
Risk

K060194 is an FDA 510(k) clearance for the MARCH HEALTHCARE HEALTH MONITORING KIT. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by March Healthcare Corporation (Ottawa, Ontario, CA). The FDA issued a Cleared decision on February 13, 2006 after a review of 19 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.

View all March Healthcare Corporation devices

FDA 510(k) Submission Details - K060194

510(k) Number K060194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2006
Decision Date February 13, 2006
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
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 America, Inc.
LAURA DANIELSON

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 858
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K060194.
RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
K060077 · Real Tone Technology Corp. · Mar 2006
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K052450 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Feb 2006
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K052676 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Feb 2006
HOCA EZ-CARE BP108, TENDER-CARE BP109
K052671 · Hoca Medical Microsystem, Inc. · Feb 2006
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K053185 · Medwave, Inc. · Jan 2006
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K051847 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Jan 2006