Cleared Traditional

K131585 - INTEL-GE CARE INNOVATIONS QUIETCARE

K131585 is an FDA 510(k) clearance for INTEL-GE CARE INNOVATIONS QUIETCARE, manufactured by Intel-Ge Care Innovations, LLC. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K131585 · Intel-Ge Care Innovations, LLC · General Hospital
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Oct 2013
Decision
130d
Days
Class 1
Risk

K131585 is an FDA 510(k) clearance for the INTEL-GE CARE INNOVATIONS QUIETCARE. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Intel-Ge Care Innovations, LLC (Roseville, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Intel-Ge Care Innovations, LLC devices

FDA 510(k) Submission Details - K131585

510(k) Number K131585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2013
Decision Date October 08, 2013
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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.