Cleared Traditional

VIVATRAK (K101109) - FDA 510(k) Clearance

Class I General Hospital device.

K101109 · Wireless Medcare, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
86d
Days
Class 1
Risk

K101109 is an FDA 510(k) clearance for the VIVATRAK. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Wireless Medcare, LLC (Marietta, US). The FDA issued a Cleared decision on July 15, 2010 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - the FDA general hospital device 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 Wireless Medcare, LLC devices

Submission Details

510(k) Number K101109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date July 15, 2010
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMI Monitor, Bed Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.