First Response Pediatric Emergency Resuscitator
FDA 510(k) K880394 · Intertech/Ohio
510(k) numberK880394
Submission
- Device name
- First Response Pediatric Emergency Resuscitator
- Applicant
- Intertech/Ohio
Fort Myers, FL, US - Received
- January 29, 1988
- Decision date
- February 29, 1988
- 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 |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K895144 | Intertech Metered Dose ElbowBZA · Traditional | 10/19/1989SE |
| K890346 | Intertech Universal Hydrophobic FilterCAH · Traditional | 03/01/1989SE |
| K884525 | Pediatric Humidifier Tube W/ Temperature PortBZO · Traditional | 12/16/1988SE |
| K884526 | Adult Resuscitator with Mask and FilterBTM · Traditional | 11/16/1988SE |
| K882204 | Resuscitator Valve Assembly W/FilterCBP · Traditional | 07/08/1988SE |
| K863033 | Patient Gas Sampling KIT/5STAND Alone VersionsBZO · Traditional | 08/20/1986SE |
| K862020 | Heat/Moisture Exchanger, Hme, W/Integral FilterBYD · Traditional | 06/30/1986SE |
| K860650 | 90 Degree Elbow & Straight ConnectorBZA · Traditional | 03/28/1986SE |
| K861056 | Straight Adapt W/Temp Sensing Port/Closure PlugBZA · Traditional | 03/27/1986SE |
Questions and answers
When was First Response Pediatric Emergency Resuscitator cleared by the FDA?
First Response Pediatric Emergency Resuscitator (K880394) received a 510(k) decision of Substantially Equivalent on February 29, 1988, 31 days after the submission was received.
What is the product code of K880394?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.