Birthwell Birthing System
by Qulab Co. 510(k)
Active
510(k) K831998
Overview
The Birthwell Birthing System is an Obstetric Table and Accessories, designed to support labor, delivery, and immediate postpartum care. It provides adjustable positioning and structural support for both the birthing individual and healthcare provider during vaginal deliveries, facilitating safe and ergonomic delivery procedures in clinical settings.
This system is intended for use in obstetric units, hospitals, or birthing centers, and is supplied as a reusable medical device. It is classified as a Class II device under FDA regulations (884.4900) and has been cleared through a Traditional 510(k) pathway. The system includes multiple registration numbers (e.g., 3040337865) for tracking and compliance, with no specific sterility or MRI safety indications stated in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831998 | Date12 Sep 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KNC
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4900
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of clinical settings is the Birthwell Birthing System intended for use in?
The Birthwell Birthing System is designed for obstetric units within hospitals or birthing centers where vaginal deliveries occur. Its adjustable positioning and support features are tailored to assist both the birthing individual and healthcare providers during labor, delivery, and immediate postpartum care.
Is the Birthwell Birthing System reusable or single-use, and how should it be maintained?
The Birthwell Birthing System is explicitly described as a reusable medical device. While the data does not specify cleaning or maintenance protocols, reusable devices typically require proper disinfection between uses to ensure hygiene and functionality. Always follow manufacturer guidelines for cleaning and sterilization.
What regulatory pathway was used for FDA clearance of the Birthwell Birthing System, and what class does it belong to?
The Birthwell Birthing System was cleared through the Traditional 510(k) pathway and is classified as a Class II device under FDA regulations (884.4900). This classification indicates it poses moderate risk and requires specific manufacturing controls to ensure safety and effectiveness.
Does the Birthwell Birthing System have any specific sterility or MRI safety considerations mentioned in the data?
The provided data does not mention any specific sterility requirements or MRI safety indications for the Birthwell Birthing System. Since it is reusable, proper cleaning and maintenance are critical for infection control, but MRI compatibility is not addressed.
How can I verify the regulatory compliance or tracking numbers for the Birthwell Birthing System?
The Birthwell Birthing System includes multiple registration numbers (e.g., 3040337865, 3007123908, etc.) for tracking and compliance. These numbers are tied to its FDA clearance (K831998) and can be used to verify its regulatory status through official FDA databases or the manufacturer’s documentation.