Capno-Flo

FDA 510(k) K933626 · Kirk Specialty Systems

Substantially Equivalent

510(k) numberK933626

Submission

Device name
Capno-Flo
Applicant
Kirk Specialty Systems
Carrollton, TX, US
Received
July 16, 1993
Decision date
October 6, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BTM – Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BTM

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K251631The BAG manual resuscitator and accessoriesBTM · Traditional Laerdal Medical AS11/24/2025SE
K243861butterflyBVMBTM · Traditional Compact Medical, Inc.04/25/2025SE
K221841EOlife®BTM · Traditional Archeon03/18/2023SE
K212905Sotair DeviceBTM · Traditional Safe Bvm Corporation08/18/2022SE
K210288Disposable Manual ResuscitatorBTM · Traditional Xiamen Compower Medical Tech. Co., Ltd.08/26/2021SE
K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional Flexicare Medical Limited.12/07/2018SE
K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional Foremount Enterprise Co., Ltd.05/11/2018SE
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated Ambu A/S08/29/2016SE
K132172Neonatalie ResuscitatorBTM · Abbreviated Laerdal Medical A/S01/15/2015SE
K112852Babi Plus Neonatal Resuscitation BagBTM · Traditional A Plus Medical01/13/2012SE

More from A Plus Medical

510(k)DeviceDecision
K962098Esophageal Intubation DetectorBTR · Traditional 10/08/1996SE
K952512Capno-Flo Regulator, Capno-FloBTM · Traditional 08/28/1995SE
K945822Capno-Flo(Tm) RegulatorCBP · Traditional 02/24/1995SE

Questions and answers

When was Capno-Flo cleared by the FDA?

Capno-Flo (K933626) received a 510(k) decision of Substantially Equivalent on October 6, 1993, 82 days after the submission was received.

What is the product code of K933626?

The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.