Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators
FDA 510(k) K042843 · Ambu, Inc.
510(k) numberK042843
Submission
- Device name
- Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators
- Applicant
- Ambu, Inc.
Linthicum, MD, US - Received
- October 14, 2004
- Decision date
- November 12, 2004
- 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 |
| 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 |
| K993278 | Ambu Neonate Silicone ResuscitatorBTM · Traditional | 05/17/2000SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | 10/25/1999SE |
Questions and answers
When was Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators cleared by the FDA?
Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators (K042843) received a 510(k) decision of Substantially Equivalent on November 12, 2004, 29 days after the submission was received.
What is the product code of K042843?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.