510(k) · Cleared
ClearedNightform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastic Surgery Solutions, LLC · FRP Holder, Infant Position
Cleared on Aug 3, 2004 as substantially equivalent to K905629 (Pedicraft, Inc., 1991) after an 8-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Aug 3, 2004
- Review
- 8 days
- Class
- Class I
- Product code
- FRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905629 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905629 Pedicraft Infant Reflux WedgePedicraft, Inc. · 1991
- This deviceK041996 NightformPlastic Surgery Solutions, LLC · 2004
- Descendant · cites it directly · 1 of its ownK062143 Kozy Comfort Infant PositionerAlfred E Mann Inst. For Biomedical Engineering · 2006
- Descendant · cites it directly · 1 of its ownK051300 Robin Hood VestKamber Corporation · 2005
- Descendant · cites it directly · 0 of its ownK082367 Infant Sleep BeanieLife Innovations, LLC · 2009
Most influential descendants
Showing 3 of 3 · See allView 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) | K041996 | Nightform | Plastic Surgery Solutions, LLC | 2004 | — |
| +1 | K062143 | Kozy Comfort Infant Positioner | Alfred E Mann Inst. For Biomedical Engineering | 2006 | — |
| +1 | K051300 | Robin Hood Vest | Kamber Corporation | 2005 | — |
| +1 | K082367 | Infant Sleep Beanie | Life Innovations, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K905629 | Pedicraft Infant Reflux WedgeSummary page 1…Classi} Predicate Device: The subject device is substantially equivalent to a predicate device Pedicraft Infant Reflux Wedge (K905629). Device Description: NightForm is a fabric-covered polyurethane foam mattress with two… | 1991 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FRP devicesFRP Holder, Infant Position: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRP
2in 2009
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 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 NightForm product is indicated for healthy infants 0-9 months to aid in the
prevention of skull deformities that can rise from consistent back-sleeping postures,
namely the condition known as deformational (or positional) plagiocephaly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041996: Nightform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041996
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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