Cleared Traditional

K113402 - SOLOHEALTH STATION

K113402 is an FDA 510(k) clearance for SOLOHEALTH STATION, manufactured by Solohealth, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K113402 · Solohealth, Inc. · Cardiovascular device
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May 2012
Decision
195d
Days
Class 2
Risk

K113402 is an FDA 510(k) clearance for the SOLOHEALTH STATION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Solohealth, Inc. (Duluth, US). The FDA issued a Cleared decision on May 30, 2012 after a review of 195 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 Solohealth, Inc. devices

FDA 510(k) Submission Details - K113402

510(k) Number K113402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2011
Decision Date May 30, 2012
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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

Underwriters Laboratories, Inc.
JEFF D RONGERO

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.

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