Cleared Traditional

K101109 - VIVATRAK

K101109 is an FDA 510(k) clearance for VIVATRAK, manufactured by Wireless Medcare, LLC. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K101109 · Wireless Medcare, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K101109

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

KMI Device Classification - Class 1, General Controls

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.

Regulatory Peers - KMI Monitor, Bed Patient

All 29
Devices cleared under the same product code (KMI) and FDA review panel - the closest regulatory comparables to K101109.
LEAF PATIENT MONITORING SYSTEM
K141877 · Leaf Healthcare, Inc. · Nov 2014
INTEL-GE CARE INNOVATIONS QUIETCARE
K131585 · Intel-Ge Care Innovations, LLC · Oct 2013
DYNASENSE SYSTEM
K130752 · Centauri Medical, Inc. · Aug 2013
MOBILECARE MONITOR, MODEL 2100
K090138 · Aframe Digital, Inc. · Apr 2009
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
K942770 · Ultimate Development Corp. · Dec 1994
INFORMER PLUS
K943481 · Micro-Tech Medical, Inc. · Nov 1994
K101109 · VIVATRAK
Download PDF FDA Summary Wireless Medcare, LLC