510(k) · Cleared

Cleared

Res-Q Infant Wedge and Sling

K090284510(k) TraditionalCleared Jun 5, 2009120-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

Cr Enterprises, LLC · FRP Holder, Infant Position

Cleared on Jun 5, 2009 as substantially equivalent to K905629 (Pedicraft, Inc., 1991) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Jun 5, 2009
Review: 120 days
Class: Class I
Product code: FRP
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K905629 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK905629 Pedicraft Infant Reflux WedgePedicraft, Inc. · 1991
This deviceK090284 Res-Q Infant Wedge and SlingCr Enterprises, LLC · 2009
Descendant · cites it directly · 0 of its ownK172962 Nurture RestNeonatal Loving Kare, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K172962Nurture RestNeonatal Loving Kare, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K090284, 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 FRP? 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? (2)

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
*	K905629	Pedicraft Infant Reflux Wedge Summary page 1 …nfant Positioner Code FRP, CFR 880.5680 Class Class 1 Pedicraft Reflux Wedge - 510(k) #K905629 Predicate Devices Tucker Sling - 510(k) #K932636 The RES-Q Infant Wedge & Sling is desig…	Pedicraft, Inc.	1991	—
*	K932636	The Tucker Sling Summary page 1 …880.5680 Class Class 1 Pedicraft Reflux Wedge - 510(k) #K905629 Predicate Devices Tucker Sling - 510(k) #K932636 The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 Intended Use months…	Tucker Designs, Ltd.	1994	—

Also cleared against K905629: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172962	Nurture Rest	Neonatal Loving Kare, Inc.	2018	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K172962 (Neonatal Loving Kare, Inc., 2018) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K905629.

How does its category compare?

All FRP devices

FRP Holder, Infant Position: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FRP

2in 2009

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRP

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

Recalls per year · FRP

No recall names FRP since 2007.

Adverse event reports per year · FRP

1in 2012

2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code FRP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	3
2009	2	—	1
2010	0	—	0
2011	0	—	0
2012	0	—	1
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastro-esophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090284 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090284: Res-Q Infant Wedge and Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090284

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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