O2N Demand-II, Victor Model OCPR-II
510(k) K992659
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992659 | Date3 Sep 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NFB
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The O2N Demand-II, Victor Model OCPR-II is an oxygen conserving device designed to deliver precise, patient-demand oxygen therapy. Classified as a conserver for oxygen (product code NFB), it operates under Class II regulatory controls and is intended for use in anesthesiology settings. This device ensures efficient oxygen delivery while minimizing waste, adhering to specialized controls for patient safety and performance.
Supplied as a reusable medical device, the O2N Demand-II is regulated under FDA 510(k) clearance (K992659) with a decision of Substantially Equivalent (SESE). It falls under regulation 868.5905 and was authorized for use in 1999. The device is intended for clinical environments where controlled oxygen delivery is required, with no specific indication of MRI compatibility or sterility requirements stated in the available data.
Other devices from Thermadyne Holings Corp.
Questions
AI-generated answers, 20 Sep 2026
What clinical setting is the O2N Demand-II, Victor Model OCPR-II primarily intended for, and how does it differ from standard oxygen delivery systems?
The O2N Demand-II is designed specifically for anesthesiology settings, where precise, patient-demand oxygen therapy is critical. Unlike standard oxygen delivery systems that provide continuous flow, this device conserves oxygen by delivering it only when the patient inhales, reducing waste and improving efficiency. This makes it ideal for controlled environments where minimizing oxygen usage aligns with patient safety and cost-effectiveness.
Is the O2N Demand-II reusable, and if so, what maintenance or cleaning considerations should be noted?
Yes, the O2N Demand-II is supplied as a reusable medical device. Since it is not sterile by design, proper cleaning and maintenance are essential to ensure functionality and patient safety. The manufacturer’s instructions (not provided here) should outline specific protocols, but generally, reusable devices require regular disinfection, inspection for wear, and calibration to maintain performance standards.
What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical practice?
The O2N Demand-II received FDA 510(k) clearance (K992659) under a Substantially Equivalent (SESE) determination, classified as a Class II device under product code NFB (Conserver, Oxygen). This means it was deemed comparable to a legally marketed predicate device, ensuring it meets established safety and performance standards for oxygen conserving devices in anesthesiology. Clinicians can rely on this clearance to confirm its regulatory compliance for controlled oxygen delivery in approved settings.
Are there multiple models or sizes available for the O2N Demand-II, and if so, how would a clinician determine the right fit for their facility?
The data provided does not specify variations in sizes or models beyond the Victor Model OCPR-II, so it appears this is the primary version. However, the device’s design as a demand-type conserver suggests it may accommodate standard oxygen cylinder connections (e.g., 1/4