Silent Partner Model 10-2001 Portable Oxygen Generator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K861011 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Silent Partner Model 10-2001 is a Portable Oxygen Generator, classified as a Class II medical device under CFR 868.5440. This device generates and delivers oxygen for clinical use, designed to provide a reliable supply of medical-grade oxygen without the need for compressed gas cylinders.
Intended for use in anesthesiology, the device is supplied as a reusable medical instrument and requires proper maintenance and calibration. It is not MRI-safe and must be stored in a clean, dry environment as specified by the manufacturer. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of April 4, 1986, and is regulated under the product code CAW.
Frequently asked questions
What is the Silent Partner Model 10-2001 primarily used for in clinical settings?
The Silent Partner Model 10-2001 is designed as a portable oxygen generator for clinical use in anesthesiology. It provides a reliable supply of medical-grade oxygen without requiring compressed gas cylinders, making it suitable for operating rooms or other anesthesia-related environments where a steady oxygen source is needed.
Is the Silent Partner Model 10-2001 single-use or reusable, and what maintenance does it require?
The Silent Partner Model 10-2001 is a reusable medical instrument. Since it is not single-use, it requires proper maintenance and calibration as specified by the manufacturer to ensure consistent performance and safety in clinical settings.
What storage conditions are recommended for the Silent Partner Model 10-2001?
The device must be stored in a clean, dry environment. The manufacturer’s guidelines should be followed to maintain optimal functionality and prevent contamination or damage.
How was the Silent Partner Model 10-2001 approved by the FDA, and what regulatory pathway was used?
The Silent Partner Model 10-2001 holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of April 4, 1986. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market under the specified regulatory route.
Can the Silent Partner Model 10-2001 be used in an MRI environment?
No, the Silent Partner Model 10-2001 is explicitly stated as not MRI-safe. It should not be used in or near MRI equipment, as this could pose risks to both the device and patients undergoing MRI procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 510 (k) Premarket Notification, Welcome to Silent Partners, Welcome to Silent Partners
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K861011 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Devices Inc.
- FDA Applicant
- Medical Devices, Inc.
Sources (1)
- FDA 510(k) K861011 24 fields · synced Sep 19, 2026