510(k) · Cleared

Cleared

Nurture Rest

K172962510(k) TraditionalCleared Jan 18, 2018114-day reviewClass I21 CFR 880.5680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neonatal Loving Kare, Inc. · OUW Infant Positioner, Rx, Use In Highly Monitored Setting

Cleared on Jan 18, 2018 as substantially equivalent to K090284 (Cr Enterprises, LLC, 2009) after a 114-day review. Its family tree reaches back 2 generations to 1991.

Decided: Jan 18, 2018
Review: 114 days
Class: Class I
Product code: OUW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K905629 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK905629 Pedicraft Infant Reflux WedgePedicraft, Inc. · 1991
1 generation backK090284 Res-Q Infant Wedge and SlingCr Enterprises, LLC · 2009
This deviceK172962 Nurture RestNeonatal Loving Kare, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K905629	Pedicraft Infant Reflux Wedge	Pedicraft, Inc.	1991	—
−1	K090284	Res-Q Infant Wedge and Sling	Cr Enterprises, LLC	2009	—
0 (this device)	K172962	Nurture Rest	Neonatal Loving Kare, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K172962, 1991–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OUW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K090284	Res-Q Infant Wedge and Sling Summary page 4 …21 CFR §880.5680 21 CFR §880.5680 Product Code: OUW FRP 510(k) Number: K161983 K090284 1 Traditional…	Cr Enterprises, LLC	2009	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 18.2 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All OUW devices

OUW Infant Positioner, Rx, Use In Highly Monitored Setting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OUW

1in 2018

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUW

Too few OUW 510(k)s in any year since 2007 to give a median.

Recalls per year · OUW

2in 2017

2007high 2 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUW

No MAUDE report names OUW since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	2	0
2018	1	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Nurture Rest (including models 100-1-O and 100-1-C) is indicated for premature infants undergoing oxygen therapy to maintain an airway and for whom treatment may be facilitated by this repositioning and stabilization device. The premature infants are being continuously monitored for oxygen saturation levels and heart rate in the Neonatal Intensive Care Unit (NICU) by medical professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172962 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172962: Nurture Rest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172962

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026