CMI Vacuum Pump
by Columbia Medical & Surgical, Inc.
510(k) K914552
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914552 | Date7 Sep 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HDA
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4400
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CMI Vacuum Pump is an obstetrical device classified as an Obstetrical Forceps under FDA regulation 884.4400. It is designed to assist in vacuum-assisted deliveries during childbirth by applying controlled suction to facilitate the safe extraction of the fetus from the birth canal. This manual vacuum pump generates and regulates negative pressure to aid obstetricians in managing labor complications or difficult deliveries.
This device is intended for single-use in clinical settings, such as hospitals and birthing centers, and requires manual operation by trained medical personnel. Supplied as a reusable pump unit, it is paired with disposable components like vacuum cups and tubing for each procedure. The pump is not MRI-safe and must be stored in a clean, dry environment per manufacturer instructions. It holds an FDA 510(k) clearance (K914552) under the Traditional review pathway, classified as Substantially Equivalent to predicate devices.
Other devices from Columbia Medical & Surgical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the CMI Vacuum Pump used for?
The CMI Vacuum Pump is designed to assist in vacuum-assisted deliveries during childbirth. It applies controlled suction to help safely extract the fetus from the birth canal, particularly in cases of labor complications or difficult deliveries. The device is classified under FDA regulation 884.4400 as an obstetrical forceps-related tool.
How is the CMI Vacuum Pump supplied and operated?
The CMI Vacuum Pump is supplied as a reusable manual pump unit, paired with disposable components like vacuum cups and tubing for each procedure. It requires manual operation by trained medical personnel in clinical settings such as hospitals or birthing centers. The reusable nature of the pump unit ensures durability, while disposable attachments maintain hygiene for single-use procedures.
Is the CMI Vacuum Pump single-use or reusable?
The CMI Vacuum Pump itself is a reusable device, designed for repeated use in clinical settings. However, disposable components such as vacuum cups and tubing are intended for single-use during each procedure to ensure sterility and hygiene. This setup allows the pump unit to remain functional across multiple deliveries while maintaining safety standards.
What storage conditions are required for the CMI Vacuum Pump?
The CMI Vacuum Pump must be stored in a clean, dry environment as per manufacturer instructions. Proper storage conditions help preserve the device’s functionality and ensure it remains ready for use in clinical settings. Avoid exposure to moisture or extreme temperatures, which could compromise the pump’s performance or hygiene.
Is the CMI Vacuum Pump MRI-safe?
No, the CMI Vacuum Pump is explicitly stated as not MRI-safe. This means it should not be used or stored in proximity to MRI machines, as the magnetic fields could potentially interfere with the device’s operation or pose safety risks. Always verify compatibility with imaging equipment before use.