Capno-Flo(Tm) Regulator

FDA 510(k) K945822 · Kirk Specialty Systems

Substantially Equivalent

510(k) numberK945822

Submission

Device name
Capno-Flo(Tm) Regulator
Applicant
Kirk Specialty Systems
Carrollton, TX, US
Received
November 29, 1994
Decision date
February 24, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CBP – Valve, Non-Rebreathing
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5870
Specialty
Anesthesiology
Life-sustaining
Yes

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K234053F&P Optiflow Flow DiverterCBP · Traditional Fisher & Paykel Healthcare, Ltd.08/09/2024SE
K210992Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional Meditera Tibbi Malzeme San VE Tic AS12/23/2021SE
K192285CPR Face ShieldCBP · Traditional Firstar Healthcare Company Limited (Guangzhou)11/25/2020SE
K173770OJR215 Pressure Relief ManifoldCBP · Traditional Fisher & Paykel Healthcare Limited04/05/2019SE
K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…CBP · Traditional Xiamen Compower Medical Tech. Co., Ltd.11/17/2017SE
K152521Seal Rite Non-Rebreathing ValveCBP · Traditional The Lifeguard Store, Inc.06/03/2016SE
K142764KYOLING CPR Mask with Oxygen Port and Without Oxygen PortCBP · Traditional Hangzhou Jinlin Medical Appliances Co., Ltd.07/09/2015SE
K142402BigEasy Non-Rebreathing ValveCBP · Traditional 12th Man Technologies, Inc.03/23/2015SE
K132143Exhalation ValveCBP · Traditional Intersurgical Incorporated06/04/2014SE

More from Intersurgical Incorporated

510(k)DeviceDecision
K962098Esophageal Intubation DetectorBTR · Traditional 10/08/1996SE
K952512Capno-Flo Regulator, Capno-FloBTM · Traditional 08/28/1995SE
K933626Capno-FloBTM · Traditional 10/06/1993SE

Questions and answers

When was Capno-Flo(Tm) Regulator cleared by the FDA?

Capno-Flo(Tm) Regulator (K945822) received a 510(k) decision of Substantially Equivalent on February 24, 1995, 87 days after the submission was received.

What is the product code of K945822?

The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.