EOlife®

FDA 510(k) K221841 · Archeon

Substantially Equivalent

510(k) numberK221841

Submission

Device name
EOlife®
Applicant
Archeon
Besançon, FR
Received
June 24, 2022
Decision date
March 18, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

510(k)DeviceApplicantDecision
K251631The BAG manual resuscitator and accessoriesBTM · Traditional Laerdal Medical AS11/24/2025SE
K243861butterflyBVMBTM · Traditional Compact Medical, Inc.04/25/2025SE
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
K102824Ambu Oval Silicone Resuscitator, Adult and PediatricBTM · Abbreviated Ambu A/S01/28/2011SE

Questions and answers

When was EOlife® cleared by the FDA?

EOlife® (K221841) received a 510(k) decision of Substantially Equivalent on March 18, 2023, 267 days after the submission was received.

What is the product code of K221841?

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