Cleared Traditional

K943017 - NEONATAL RESTRAINT AND COMFORT SYSTEMS

K943017 is an FDA 510(k) clearance for NEONATAL RESTRAINT AND COMFORT SYSTEMS, manufactured by K.Bowmed, Inc.. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K943017 · K.Bowmed, Inc. · General Hospital
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Jan 1995
Decision
209d
Days
Class 1
Risk

K943017 is an FDA 510(k) clearance for the NEONATAL RESTRAINT AND COMFORT SYSTEMS. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by K.Bowmed, Inc. (North Wilkesboro, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 209 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5680 - 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 K.Bowmed, Inc. devices

FDA 510(k) Submission Details - K943017

510(k) Number K943017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1994
Decision Date January 19, 1995
Days to Decision 209 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
80d slower than avg
Panel avg: 129d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

FRP Device Classification - Class 1, General Controls

Product Code FRP Holder, Infant Position
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5680
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.