First Medic Pulse Oximetry Module
510(k) K955890
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955890 | Date28 Jul 1997 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The FirstMedic Pulse Oximetry Module is a pulse oximetry device designed to measure and display oxygen saturation levels in blood (SpO₂) and pulse rate. It is classified as a non-wearable automated external defibrillator accessory, intended for use in cardiovascular monitoring and emergency response settings.
This device is supplied as a reusable module and is intended for use in clinical environments such as hospitals, emergency rooms, and pre-hospital care settings. It operates under FDA 510(k) clearance (K955890) and is regulated under the Federal Food, Drug, and Cosmetic Act as a Class III device (product code MKJ). No specific sterility or MRI safety information is provided in the data.
Other devices from Colorado Medtech, Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical settings is this pulse oximetry module designed for and how is it typically used?
The FirstMedic Pulse Oximetry Module is specifically designed for use in cardiovascular monitoring and emergency response environments. It is intended for clinical settings such as hospitals, emergency rooms, and pre-hospital care, where real-time monitoring of oxygen saturation (SpO₂) and pulse rate is critical. It functions as an accessory to non-wearable automated external defibrillators, providing continuous vital sign data to aid in patient assessment and treatment decisions during emergencies.
Is this device single-use or reusable, and what does that mean for maintenance in a clinical environment?
The FirstMedic Pulse Oximetry Module is supplied as a reusable device, meaning it is intended for repeated use in clinical settings. This design allows for ongoing monitoring without the need for disposable components, but it also requires proper cleaning, disinfection, and maintenance protocols to ensure accuracy, reliability, and infection control between uses. Facilities must follow manufacturer guidelines to uphold performance and safety standards.
What regulatory pathway was followed for this device, and what does that imply for its use?
The FirstMedic Pulse Oximetry Module was cleared through the FDA’s 510(k) pathway (K955890) under the Federal Food, Drug, and Cosmetic Act as a Class III device (product code MKJ). This clearance indicates that the device was deemed substantially equivalent to a legally marketed predicate device and is regulated under strict standards for cardiovascular monitoring equipment. Clinicians and facilities can rely on this regulatory history to confirm its compliance with safety and performance requirements for emergency and clinical use.
Are there any specific storage requirements for this device to maintain its functionality?
The provided data does not specify sterility or detailed storage instructions for the FirstMedic Pulse Oximetry Module. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and sources of electromagnetic interference. Facilities should follow the manufacturer’s guidelines to preserve calibration, accuracy, and overall functionality, particularly in environments where it may be exposed to moisture or physical stress.