510(k) · Cleared
ClearedPedicraft Infant Reflux Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pedicraft, Inc. · FRP Holder, Infant Position
Cleared on Mar 13, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 13, 1991
- Review
- 89 days
- Class
- Class I
- Product code
- FRP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK905629 Pedicraft Infant Reflux WedgePedicraft, Inc. · 1991
- Descendant · cites it directly · 3 of its ownK041996 NightformPlastic Surgery Solutions, LLC · 2004
- Descendant · cites it directly · 1 of its ownK090284 Res-Q Infant Wedge and SlingCr Enterprises, LLC · 2009
- Descendant · cites it directly · 1 of its ownK062143 Kozy Comfort Infant PositionerAlfred E Mann Inst. For Biomedical Engineering · 2006
- Descendant · 2 generations on · 1 of its ownK051300 Robin Hood VestKamber Corporation · 2005
- Descendant · 2 generations on · 0 of its ownK172962 Nurture RestNeonatal Loving Kare, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041996NightformPlastic Surgery Solutions, LLC · 2004 · cites it directly3descendants
- K090284Res-Q Infant Wedge and SlingCr Enterprises, LLC · 2009 · cites it directly1descendant
- K062143Kozy Comfort Infant PositionerAlfred E Mann Inst. For Biomedical Engineering · 2006 · cites it directly1descendant
- K051300Robin Hood VestKamber Corporation · 2005 · 2 generations on1descendant
- K172962Nurture RestNeonatal Loving Kare, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905629 | Pedicraft Infant Reflux Wedge | Pedicraft, Inc. | 1991 | — |
| +1 | K041996 | Nightform | Plastic Surgery Solutions, LLC | 2004 | — |
| +1 | K090284 | Res-Q Infant Wedge and Sling | Cr Enterprises, LLC | 2009 | — |
| +1 | K062143 | Kozy Comfort Infant Positioner | Alfred E Mann Inst. For Biomedical Engineering | 2006 | — |
| +2 | K051300 | Robin Hood Vest | Kamber Corporation | 2005 | — |
| +2 | K172962 | Nurture Rest | Neonatal Loving Kare, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K041996 (Plastic Surgery Solutions, LLC, 2004) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K905629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905629: Pedicraft Infant Reflux Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905629
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026