Critikon Company, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 51
What Critikon Company, LLC makes
Critikon Company, LLC manufactures automated blood pressure monitoring devices, including the Dinamap Vital Signs Monitor series (e.g., Models 9300, 8100T, 1846 SX, Pro Series) for continuous or intermittent cuff-based measurements, as well as central station monitors for multi-patient vital sign tracking. The company also produces infusion pumps like the RateMinder V for controlled intravenous fluid delivery, IV catheter placement units, and disposable IV sets. Additional offerings include electrode/cathéter systems for monitoring and infusion applications, along with modular components like the Sim Module for simulation training.
The company’s devices are classified under FDA categories Class I (low-risk, e.g., IV sets), Class II (moderate-risk, e.g., infusion pumps and vital sign monitors), and Class III (high-risk, e.g., central station monitors requiring premarket approval). Products are listed in the FDA’s 510(k) registry, demonstrating compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 51 devicesShowing 1-50 of 51
Frequently asked questions
How many devices does Critikon Company, LLC have in the registry?
The registry currently lists 51 devices for Critikon Company, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Critikon Company, LLC's devices?
Among its 50 most recently registered devices, Critikon Company, LLC has devices listed in FDA 510(k) (50 devices).
What risk classes do Critikon Company, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Critikon Company, LLC's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Critikon Company, LLC in the registry?
The most recently registered devices listed for Critikon Company, LLC include DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340, SIMPLICITY PLUS, DINAMAP VITAL SIGNS MONITOR, MODEL 8100T and IV SETS.