Cleared Traditional

K925529 - WANDER CARE

K925529 is an FDA 510(k) clearance for WANDER CARE, manufactured by Care Electronics, Inc.. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K925529 · Care Electronics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
226d
Days
Class 1
Risk

K925529 is an FDA 510(k) clearance for the WANDER CARE. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Care Electronics, Inc. (Boulder, US). The FDA issued a Cleared decision on June 16, 1993 after a review of 226 days - an extended review 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: 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 Care Electronics, Inc. devices

FDA 510(k) Submission Details - K925529

510(k) Number K925529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date June 16, 1993
Days to Decision 226 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 129d · This submission: 226d
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.