Cleared Traditional

K172962 - Nurture Rest

K172962 is an FDA 510(k) clearance for Nurture Rest, manufactured by Neonatal Loving Kare, Inc.. The device is a Class 1 General Hospital device with product code OUW cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K172962 · Neonatal Loving Kare, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
114d
Days
Class 1
Risk

K172962 is an FDA 510(k) clearance for the Nurture Rest. Classified as Infant Positioner, Rx, Use In Highly Monitored Setting (product code OUW), Class I - General Controls.

Submitted by Neonatal Loving Kare, Inc. (Dubois, US). The FDA issued a Cleared decision on January 18, 2018 after a review of 114 days - within the typical 510(k) review window.

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 Neonatal Loving Kare, Inc. devices

FDA 510(k) Submission Details - K172962

510(k) Number K172962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date January 18, 2018
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

OUW Device Classification - Class 1, General Controls

Product Code OUW Infant Positioner, Rx, Use In Highly Monitored Setting
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5680
Definition Designed To Position The Baby At A 30 Degree Angle In The Prone (on His/her Stomach) Position For Specific Medical Or Surgical Conditions. For Use Only When In A Highly Monitored Setting With Continuous Cardio-respiratory And Oxygen Saturation Monitoring.
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.

Regulatory Consultant

Regulatory and Quality Solutions, Inc.
Nicole Spaniel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.