Not Cleared Direct

DEN150053 - FETAL PILLOW (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150053 · Safe Obstetric Systems, Ltd. · Obstetrics & Gynecology device
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Jul 2017
Decision
617d
Days
Class 2
Risk

DEN150053 is an FDA 510(k) submission (not cleared) for the FETAL PILLOW. Classified as Fetal Head Elevator (product code PWB), Class II - Special Controls.

Submitted by Safe Obstetric Systems, Ltd. (Shenfield, GB). The FDA issued a Not Cleared (DENG) decision on July 27, 2017 after a review of 617 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4350 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 617 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Safe Obstetric Systems, Ltd. devices

Submission Details

510(k) Number DEN150053 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 18, 2015
Decision Date July 27, 2017
Days to Decision 617 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
457d slower than avg
Panel avg: 160d · This submission: 617d
Pathway characteristics

Device Classification

Product Code PWB Fetal Head Elevator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4350
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.