Servo Ventilator System, Model 64 87 800 E407E
by Siemens Medical Solutions USA, Inc.
510(k) K022132
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022132 | Date19 Sep 2002 | 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- Withdrawn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
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Servo Ventilator System, Model 64 87 800 E407E is a continuous ventilator designed for facility use. It provides mechanical respiratory support to patients across neonatal, pediatric, and adult populations by delivering controlled ventilation therapy and monitoring respiratory parameters in clinical settings.
This device is intended for use in hospital environments, including bedside and in-hospital transport, and is operated by trained healthcare professionals. It is classified as a Class II medical device under FDA regulations (Regulation Number 868.5895) and has received FDA 510(k) clearance via a Special Advisory Committee review (AN). The system is not described as single-use or reusable in the provided data, nor are MRI safety or sterility specifications mentioned.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
What patient populations can the Servo Ventilator System, Model 64 87 800 E407E support, and where is it typically used within a hospital?
The Servo Ventilator System is designed to provide mechanical respiratory support across neonatal, pediatric, and adult patient populations. It is intended for facility use, meaning it is primarily deployed in hospital environments, including bedside care and in-hospital transport. The device is operated by trained healthcare professionals, ensuring safe and controlled ventilation therapy.
Is the Servo Ventilator System reusable or single-use, and what are the storage requirements?
The provided data does not specify whether the Servo Ventilator System is single-use or reusable. However, as it is a facility-use ventilator, it is typically designed for repeated use in clinical settings. Storage requirements are not detailed, but such devices generally require protection from extreme temperatures, humidity, and physical damage. Always follow manufacturer guidelines for optimal performance and longevity.
How was the FDA clearance for this ventilator obtained, and which advisory committee was involved?
The Servo Ventilator System received FDA 510(k) clearance through a Special Advisory Committee review, specifically the Anesthesiology (AN) Advisory Committee. The clearance was granted under the classification of a Class II medical device (Regulation Number 868.5895) and was determined to be substantially equivalent to a predicate device. This process ensures the device meets regulatory standards for safety and effectiveness.
Can this ventilator be used for patients requiring transport within the hospital, and if so, what considerations should be taken?
Yes, the Servo Ventilator System is intended for in-hospital transport in addition to bedside use. When transporting patients, it is critical to ensure the device remains stable, power is uninterrupted, and all connections (e.g., tubing, alarms) are secure. Since it is a facility-use device, it is designed for controlled clinical environments, so transport should follow hospital protocols to maintain patient safety and device integrity.