Cleared Traditional

K243799 - Fetal Pillow (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243799 · CooperSurgical, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2025
Decision
261d
Days
Class 2
Risk

K243799 is an FDA 510(k) clearance for the Fetal Pillow. Classified as Fetal Head Elevator (product code PWB), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on August 29, 2025 after a review of 261 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperSurgical, Inc. devices

Submission Details

510(k) Number K243799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2024
Decision Date August 29, 2025
Days to Decision 261 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 160d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.