Ambu Neonate Silicone Resuscitator
FDA 510(k) K993278 · Ambu, Inc.
510(k) numberK993278
Submission
- Device name
- Ambu Neonate Silicone Resuscitator
- Applicant
- Ambu, Inc.
Linthicum, MD, US - Received
- September 30, 1999
- Decision date
- May 17, 2000
- 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 |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K051529 | Ambu Neuroline GroundGXY · Traditional | 08/04/2005SE |
| K042682 | Ambu Spur Ii. Adult Single Patient ResuscitatorBTM · Traditional | 11/15/2004SE |
| K042843 | Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsBTM · Traditional | 11/12/2004SE |
| K041734 | Ambu Disposable ECG ElectrodeDRX · Traditional | 09/22/2004SE |
| K040991 | Ambu Disposable Pressure ManometerCAP · Traditional | 07/22/2004SE |
| K041026 | Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-SDRX · Traditional | 06/28/2004SE |
| K032278 | Ambu Neuroline Single Patient Eeg/Ep Cup ElectrodeGXY · Traditional | 03/05/2004SE |
| K032421 | Ambu Pediatric Multi-Function Defibrillation ElectrodeMKJ · Traditional | 02/27/2004SE |
| K010583 | Ambu Gel, Hydrogel Burn DressingMGQ · Traditional | 05/25/2001SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | 10/25/1999SE |
Questions and answers
When was Ambu Neonate Silicone Resuscitator cleared by the FDA?
Ambu Neonate Silicone Resuscitator (K993278) received a 510(k) decision of Substantially Equivalent on May 17, 2000, 230 days after the submission was received.
What is the product code of K993278?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.