De Novo · Granted
GrantedFetal Pillow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safe Obstetric Systems, Ltd. · PWB Fetal Head Elevator
Granted on Jul 27, 2017 as a new device type through De Novo after a 617-day review. 1 later device descends from it.
- Decided
- Jul 27, 2017
- Review
- 617 days
- Class
- Class II
- Product code
- PWB
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN150053 Fetal PillowSafe Obstetric Systems, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK243799 Fetal PillowCooperSurgical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243799Fetal PillowCooperSurgical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150053 | Fetal Pillow | Safe Obstetric Systems, Ltd. | 2017 | — |
| +1 | K243799 | Fetal Pillow | CooperSurgical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 PWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PWB device
- #1 K243799 Fetal Pillowscore 9.9 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243799 | Fetal Pillow | 2025 | 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?
- Of its descendants, K243799 (CooperSurgical, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PWB devicesPWB Fetal Head Elevator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PWB
Too few PWB 510(k)s in any year since 2007 to give a median.
Recalls per year · PWB
No recall names PWB since 2007.
Adverse event reports per year · PWB
1in 2025
MAUDE reports naming product code PWB, 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 | 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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150053 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN150053: Fetal Pillow.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN150053
Report an extraction error
Are you the manufacturer?
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