Kirk Specialty Systems
Country not established
- Devices
- 4
What Kirk Specialty Systems makes
Kirk Specialty Systems manufactures devices for monitoring and confirming endotracheal intubation, including the Esophageal Intubation Detector and the Capno-Flo line of capnography regulators. These products are designed to assist in verifying tube placement during respiratory procedures by measuring exhaled carbon dioxide levels.
The company’s portfolio consists of Class II medical devices, which are regulated under the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Esophageal Intubation Detector Ref K962098
Regimes: 510(k) Registry: 510(k)Capno-Flo Ref K933626
Regimes: 510(k) Registry: 510(k)Capno-Flo Regulator, Capno-Flo Ref K952512
Regimes: 510(k) Registry: 510(k)Capno-Flo(Tm) Regulator Ref K945822
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kirk Specialty Systems have in the registry?
The registry currently lists 4 devices for Kirk Specialty Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kirk Specialty Systems's devices?
Among its 4 most recently registered devices, Kirk Specialty Systems has devices listed in FDA 510(k) (4 devices).
What risk classes do Kirk Specialty Systems's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Kirk Specialty Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kirk Specialty Systems in the registry?
The most recently registered devices listed for Kirk Specialty Systems include ESOPHAGEAL INTUBATION DETECTOR, CAPNO-FLO, CAPNO-FLO REGULATOR, CAPNO-FLO and CAPNO-FLO(TM) REGULATOR.