EMS Single Use Manual Resuscitators
FDA 510(k) K912203 · Engineered Medical Systems
510(k) numberK912203
Submission
- Device name
- EMS Single Use Manual Resuscitators
- Applicant
- Engineered Medical Systems
Indianapolis, IN, US - Received
- May 20, 1991
- Decision date
- November 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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|---|---|---|
| K220533 | Endoscopy Oxygen MaskCCK · Traditional | 11/16/2022SE |
| K062104 | Talking TrachBTO · Traditional | 04/20/2007SE |
| K023683 | Multi-Strap Full Face MaskBZD · Traditional | 12/01/2003SE |
| K013728 | Trach VoxJOH · Traditional | 07/30/2002SE |
| K013122 | EMS Electrostatic Fliter and Hme CombinationCAH · Traditional | 04/19/2002SE |
| K013123 | EMS Pulmonary Function Testing FilterBZG · Traditional | 03/14/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | 03/14/2002SE |
| K003497 | Disposable Pressure MonitorCAP · Traditional | 11/30/2000SE |
| K000215 | Swivel ElbowBZD · Traditional | 05/26/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | 04/12/2000SE |
Questions and answers
When was EMS Single Use Manual Resuscitators cleared by the FDA?
EMS Single Use Manual Resuscitators (K912203) received a 510(k) decision of Substantially Equivalent on November 13, 1991, 177 days after the submission was received.
What is the product code of K912203?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.