Atcor Medical
AU Last updated 22 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 3
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Conneqt Pulse Ref K221742
Sphygmocor Xcel Ref K122129
What Atcor Medical makes
Atcor Medical manufactures non-invasive blood pressure monitoring devices, including the CONNEQT PULSE for continuous pulse waveform analysis and the SPHYGMOCOR XCEL for automated oscillometric measurements. The company also provides software modifications for the SPHYGMOCOR Cardiovascular Management System, which supports cardiovascular health assessments.
These devices are classified under Class II by the FDA and are subject to 510(k) clearance requirements. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does Atcor Medical manufacture?
Atcor Medical specializes in non-invasive blood pressure monitoring devices. Their portfolio includes the CONNEQT PULSE, designed for continuous pulse waveform analysis, and the SPHYGMOCOR XCEL, which automates oscillometric blood pressure measurements. They also offer software modifications for the SPHYGMOCOR Cardiovascular Management System, a tool used for cardiovascular health assessments.
Where is Atcor Medical based?
Atcor Medical is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to FDA requirements.
How are Atcor Medical’s devices classified by the FDA?
Atcor Medical’s devices fall under FDA Class II classification. This classification means they pose moderate risk and require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.
Are Atcor Medical’s devices listed in any regulatory registries?
Yes, Atcor Medical’s devices are included in the FDA’s 510(k) database. This registry tracks devices that have undergone 510(k) clearance, ensuring transparency about their regulatory status and compliance with FDA requirements.
Why do Atcor Medical’s devices require 510(k) clearance?
The FDA’s 510(k) clearance process is required for Class II devices like those made by Atcor Medical because they are considered to have moderate risk. The process ensures that each device meets safety and effectiveness standards by demonstrating equivalence to a previously cleared predicate device, thereby reducing the need for extensive clinical trials.
Information
- Country
- AU