510(k) · Cleared

Cleared

Infant Sleep Beanie

K082367510(k) TraditionalCleared Jun 12, 2009298-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

Life Innovations, LLC · FRP Holder, Infant Position

Cleared on Jun 12, 2009 as substantially equivalent to K062143 (Alfred E Mann Inst. For Biomedical Engineering, 2006) and 3 other predicates after a 298-day review. Its family tree reaches back 3 generations to 1991.

Decided: Jun 12, 2009
Review: 298 days
Class: Class I
Product code: FRP
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K905629 (1991). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK905629 Pedicraft Infant Reflux WedgePedicraft, Inc. · 1991
2 generations backK041996 NightformPlastic Surgery Solutions, LLC · 2004
1 generation backK051300 Robin Hood VestKamber Corporation · 2005
This deviceK082367 Infant Sleep BeanieLife Innovations, LLC · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K905629	Pedicraft Infant Reflux Wedge	Pedicraft, Inc.	1991	—
−2	K041996	Nightform	Plastic Surgery Solutions, LLC	2004	—
−1	K051300	Robin Hood Vest	Kamber Corporation	2005	—
0 (this device)	K082367	Infant Sleep Beanie	Life Innovations, LLC	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0

FIG. 1 — Lineage of K082367, 1991–2009Source: 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? (4)

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
*	K062143	Kozy Comfort Infant Positioner Summary page 1 …Classification: Class I (reserved) Classification Code: FRP Predicate Device(s): Kozy Comfort T M Infant Positioner K062143 Head Bed Tm Infant Positioner K060986 Robin Hood VestTM…	Alfred E Mann Inst. For Biomedical Engineering	2006	—
*	K060986	Head Bed Summary page 1 …cation Code: FRP Predicate Device(s): Kozy Comfort T M Infant Positioner K062143 Head Bed Tm Infant Positioner K060986 Robin Hood VestTM K051300 Nightform Tm Infant Sleep…	Steven H. Warnock, M.D.	2006	—
*	K051300	Robin Hood Vest Summary page 1 …K062143 Head Bed Tm Infant Positioner K060986 Robin Hood VestTM K051300 Nightform Tm Infant Sleep Positioner K041996 Device Description: The Life Innovations Infa…	Kamber Corporation	2005	—
*	K041996	Nightform Summary page 1 …K060986 Robin Hood VestTM K051300 Nightform Tm Infant Sleep Positioner K041996 Device Description: The Life Innovations Infant Sleep Beanie is a form fitting infant beanie hat place…	Plastic Surgery Solutions, LLC	2004	—

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 18 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
None of the 5 ancestors has a recall.

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 Life Innovations Infant Sleep Beanie is an over-the-counter repositioning device to aid ift the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082367 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082367: Infant Sleep Beanie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082367

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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