Cleared Traditional

NEONATAL RESTRAINT AND COMFORT SYSTEMS (K943017) - FDA 510(k) Clearance

Class I General Hospital device.

K943017 · K.Bowmed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.