Ohmeda Tec 6 Continuous Flow Vaporizer, NAD
by Ohmeda Anesthesia Systems Therapy Group
510(k) K925580
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925580 | Date2 Jun 1993 | StatusActive |
Recalls
-
- Terminated Z-2161-2013
GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Ohmeda Tec 6 (Cfv) Continuous Flow Vaporizer, Nad
- 510(k) Number
- FDA Product Code
- BSZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5160
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Ohmeda Tec 6 Continuous Flow Vaporizer, NAD, is a Gas-Machine, Anesthesia device designed for vaporizing desflurane anesthetic agent during inhalation anesthesia. It employs an electrically powered, heated vaporization system to ensure stable vapor delivery under controlled temperature and pressure, meeting the specific requirements of desflurane administration.
This device is intended for use in operating rooms and anesthesia care settings, supplied as a reusable medical instrument. It adheres to FDA 510(k) clearance (K925580) under the Anesthesiology advisory committee and falls under Device Class II (regulation number 868.5160). The vaporizer is not single-use and requires proper storage and maintenance to ensure functionality and safety in clinical environments.
Other devices from Ohmeda Anesthesia Systems Therapy Group
Questions
AI-generated answers, 19 Sep 2026
What anesthetic agent is this vaporizer specifically designed to deliver, and why is that important for clinical use?
This vaporizer is specifically designed to deliver desflurane, a potent inhalation anesthetic. The electrically powered, heated vaporization system ensures stable and precise delivery of desflurane under controlled temperature and pressure, which is critical for safe and effective anesthesia administration. Desflurane’s low blood-gas solubility allows for rapid induction and recovery, making this vaporizer well-suited for procedures requiring quick patient turnover or precise dose control.
Is this vaporizer intended for single-use or reusable applications, and what maintenance does it require?
The Ohmeda Tec 6 Continuous Flow Vaporizer is not single-use—it is designed as a reusable medical instrument. Since it operates in high-stakes environments like operating rooms, proper storage and regular maintenance are essential to ensure functionality, safety, and compliance with clinical standards. The manufacturer likely provides guidelines for cleaning, calibration, and servicing to sustain performance over repeated use.
How is this device regulated in the U.S., and what does the advisory committee classification mean for its use?
This device holds FDA 510(k) clearance (K925580) under the Anesthesiology Advisory Committee, classifying it as Device Class II (regulation number 868.5160). The advisory committee classification indicates it was reviewed by experts in anesthesia to ensure safety and effectiveness for vaporizing desflurane during inhalation anesthesia. This route confirms it meets U.S. regulatory standards for use in operating rooms and anesthesia care settings.
What types of clinical settings is this vaporizer intended for, and why is that relevant?
The device is explicitly designed for use in operating rooms and anesthesia care settings, where precise control of desflurane delivery is required. This specification ensures compatibility with surgical environments where rapid adjustments to anesthesia depth may be necessary, such as during general anesthesia procedures. Its design aligns with the demands of clinical workflows where reliability and stability of anesthetic delivery are paramount.
Are there multiple models or configurations of this vaporizer, and how might that affect selection?
The provided data lists multiple FEI numbers (e.g., 3013188547, 3005783425), which typically correspond to different model variants or configurations of the vaporizer. While the exact differences aren’t detailed here, these variations may include differences in technical specifications, compatibility with anesthesia machines, or regional adaptations. Clinicians or buyers should verify compatibility with their existing anesthesia systems and consult manufacturer documentation to select the appropriate model for their needs.