Demand Oxygen Sauer DOS2 Model 10
by Applied Membrane Technology, Inc.
510(k) K851235
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851235 | Date30 Apr 1985 | 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- Withdrawn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, 1 Oct 2026
The Demand Oxygen Sauer Dos2 Model 10 is a conserver, oxygen device classified under 21 CFR 868.5905. It is designed to deliver oxygen to patients in controlled, demand-driven bursts, ensuring precise gas delivery during medical procedures, particularly in anesthesiology settings. The device operates by responding to the patient’s inhalation, providing oxygen only when needed to maintain respiratory support. Its primary function is to conserve oxygen while ensuring adequate supply during critical phases of anesthesia or apnea monitoring.
This device is intended for single-use or reusable applications in clinical environments, though specific sterility or reuse instructions are not detailed in the provided data. It is regulated under FDA 510(k) clearance (K851235) and falls under the advisory committee for Anesthesiology. The device is supplied as a demand oxygen controller system, with no explicit mention of MRI safety or size variations in the available records. Storage and handling conditions are not specified beyond standard medical device protocols. The authorization reflects a traditional 510(k) submission with a Substantially Equivalent (SESE) decision.
Other devices from Applied Membrane Technology, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Sauer Dos2 Model 10?
The Sauer Dos2 Model 10 is a demand oxygen conserver designed to deliver oxygen in controlled, patient-triggered bursts during medical procedures, particularly in anesthesiology. It ensures precise gas delivery while conserving oxygen, making it ideal for maintaining respiratory support during anesthesia or apnea monitoring without excessive waste.
Is the Sauer Dos2 Model 10 intended for single-use or reusable applications?
The Sauer Dos2 Model 10 is specified for either single-use or reusable applications in clinical settings. However, the provided data does not detail sterility requirements or reuse instructions, so proper validation and cleaning protocols must be followed if reuse is intended.
What regulatory pathway does the Sauer Dos2 Model 10 follow?
The Sauer Dos2 Model 10 is regulated under the FDA’s 510(k) clearance pathway, specifically with a Substantially Equivalent (SESE) decision under the Anesthesiology advisory committee. This classification reflects its use as a conserver, oxygen device under 21 CFR 868.5905.
Does the Sauer Dos2 Model 10 have any specified size variations or MRI safety considerations?
The available records for the Sauer Dos2 Model 10 do not mention size variations or MRI safety. Clinicians should verify compatibility with their specific MRI systems if use in such environments is planned.
What storage and handling guidelines apply to the Sauer Dos2 Model 10?
The Sauer Dos2 Model 10 does not have explicit storage or handling conditions detailed in the provided data. As a standard medical device, it should be stored in accordance with general medical device protocols to maintain functionality and sterility (if applicable). Always follow manufacturer recommendations for optimal performance.