Heater Oximeter System
by Oximetrix, Inc. 510(k)
Active
510(k) K781879
Overview
The Heater Oximeter System is a component that provides temperature regulation for an oximeter monitoring system. It is classified as a Class II medical device and is intended to maintain optimal operating conditions for accurate oxygen saturation measurements.
The device was cleared by the FDA through a traditional 510(k) submission (K781879) in 1979 and is listed under product code DQA. It is manufactured by Oximetrix, Inc. in Mchenry, Illinois, United States, and is identified as a single model without additional size variants.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781879 | Date8 Jan 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Oximetrix, Inc.
Questions
What is the primary function of the Heater Oximeter System?
The system’s sole function is to regulate the temperature of an oximeter monitoring unit. By maintaining a stable, optimal temperature, it helps the oximeter produce reliable oxygen saturation measurements, which are critical for accurate patient monitoring.
Is the Heater Oximeter System available in multiple sizes or models?
No, the device is offered as a single, non‑variant model. The FDA clearance and product listing identify only one configuration, so clinicians do not need to select among different sizes or versions.
Is the Heater Oximeter System supplied sterile and can it be reused?
The device is not described as a sterile, single‑use product. Because it is a temperature‑regulation component rather than a direct patient‑contact item, it is typically supplied non‑sterile and can be used repeatedly according to the manufacturer’s maintenance guidelines.
How is the Heater Oximeter System packaged and delivered?
The data do not specify packaging details, but as a Class II medical device cleared through a 510(k) submission, it is normally shipped in a protective, non‑sterile container suitable for safe transport to healthcare facilities.
What regulatory pathway was used for the Heater Oximeter System’s clearance?
The system received clearance via a traditional 510(k) submission (K781879) in 1979, indicating it was found substantially equivalent to a legally marketed predicate device and classified under product code DQA as a Class II device.