Onyx Finger Clip Pulse Oximeter, Model 9500
510(k) K001085
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001085 | Date1 May 2000 | 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- Withdrawn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
- Full name
- Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500
- 510(k) Number
- FDA Product Code
- DQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Onyx Finger Clip Pulse Oximeter, Model 9500, is a non-invasive medical device designed to measure and display oxygen saturation (SpO₂) and pulse rate in patients. It operates by transmitting light through a finger clip sensor to determine hemoglobin oxygenation levels, providing real-time vital sign monitoring. This device is classified under the category of pulse oximeters, which are critical for assessing respiratory and circulatory function in clinical and home settings.
The Model 9500 is supplied as a reusable device, intended for use in healthcare environments such as hospitals, clinics, and emergency care. It requires no special sterility conditions beyond standard disinfection protocols between patient use. The device is regulated under FDA 510(k) clearance (K001085) and falls under the product code DQA, with a decision classification of Substantially Equivalent. No specific MRI safety or size variations are noted in the regulatory data.
Other devices from Nonin Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Onyx Model 9500 Finger Clip Pulse Oximeter used for?
The Onyx Model 9500 is a non-invasive medical device designed to measure and display oxygen saturation (SpO₂) and pulse rate in patients. It uses a finger clip sensor to transmit light through the finger, determining hemoglobin oxygenation levels. This helps clinicians assess respiratory and circulatory function in real-time, making it essential for monitoring patients in hospitals, clinics, and emergency care settings.
How is the Onyx Model 9500 supplied and what are its reuse requirements?
The Onyx Model 9500 is supplied as a reusable device, intended for use in healthcare environments. Between patient uses, it must follow standard disinfection protocols to ensure safety and hygiene. Unlike single-use devices, this model is built for repeated clinical applications, reducing waste while maintaining accuracy.
Does the Onyx Model 9500 require special sterility conditions?
No special sterility conditions are required beyond standard disinfection protocols between patient uses. The device is designed for clinical reuse, so proper cleaning and disinfection—such as with alcohol wipes or hospital-grade disinfectants—are sufficient to maintain its performance and safety.
Are there different sizes or models available for the Onyx pulse oximeter?
The Onyx Model 9500 is a single model designed as a finger clip pulse oximeter. No size variations or additional models are noted in the regulatory data for this specific device, making it a standardized option for finger-based monitoring.
What regulatory approval does the Onyx Model 9500 have?
The Onyx Model 9500 has received FDA 510(k) clearance under the classification of Substantially Equivalent (SESE) with the decision code K001085. This approval confirms its compliance with U.S. safety and performance standards for pulse oximeters, ensuring it meets regulatory requirements for clinical use.