Air Viva II
FDA 510(k) K802231 · General Medical Co.
510(k) numberK802231
Submission
- Device name
- Air Viva II
- Applicant
- General Medical Co.
Mchenry, IL, US - Received
- September 15, 1980
- Decision date
- October 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | Laerdal Medical AS | 11/24/2025SE |
| K243861 | butterflyBVMBTM · Traditional | Compact Medical, Inc. | 04/25/2025SE |
| K221841 | EOlife®BTM · Traditional | Archeon | 03/18/2023SE |
| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
| K210288 | Disposable Manual ResuscitatorBTM · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 08/26/2021SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | Flexicare Medical Limited. | 12/07/2018SE |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
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| K926269 | Procedure KitLRO · Traditional | 08/27/1993SEKD |
| K912975 | Operand Lubricating JellyKMJ · Traditional | 09/27/1991SE |
| K912132 | Operand Lubricating JellyFHX · Traditional | 08/07/1991SE |
| K903669 | Genesis Insufflating CatheterBSY · Traditional | 09/12/1990SE |
| K900110 | Operand* Lubricating JellyKMJ · Traditional | 05/02/1990SE |
| K853635 | Subderm TMEGJ · Traditional | 12/20/1985SE |
| K844652 | C.A.S.E. ContainerFSM · Traditional | 12/12/1984SE |
| K831320 | DrionicEGJ · Traditional | 07/19/1983SE |
| K820689 | C.S.R. WrappersFRG · Traditional | 04/09/1982SE |
| K820521 | Sterilization WrapFRG · Traditional | 03/18/1982SE |
Questions and answers
When was Air Viva II cleared by the FDA?
Air Viva II (K802231) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 25 days after the submission was received.
What is the product code of K802231?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.