Cleared Traditional

K934344 - HOME AMB-ALERT

K934344 is an FDA 510(k) clearance for HOME AMB-ALERT, manufactured by Medway. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K934344 · Medway · General Hospital
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Apr 1994
Decision
233d
Days
Class 1
Risk

K934344 is an FDA 510(k) clearance for the HOME AMB-ALERT. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Medway (Franklin, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 233 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 Medway devices

FDA 510(k) Submission Details - K934344

510(k) Number K934344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1993
Decision Date April 29, 1994
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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.