Cleared Traditional

K141877 - LEAF PATIENT MONITORING SYSTEM

K141877 is an FDA 510(k) clearance for LEAF PATIENT MONITORING SYSTEM, manufactured by Leaf Healthcare, Inc.. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K141877 · Leaf Healthcare, Inc. · General Hospital
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Nov 2014
Decision
122d
Days
Class 1
Risk

K141877 is an FDA 510(k) clearance for the LEAF PATIENT MONITORING SYSTEM. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Leaf Healthcare, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 10, 2014 after a review of 122 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 Leaf Healthcare, Inc. devices

FDA 510(k) Submission Details - K141877

510(k) Number K141877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2014
Decision Date November 10, 2014
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
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.