SPUR ADULT WITH OPEN RESERVOIR SYSTEM
FDA 510(k) clearance K922707 · decided 1992-06-19
Clearance details
- K-number
- K922707
- Device name
- SPUR ADULT WITH OPEN RESERVOIR SYSTEM
- Applicant
- Ambu, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-05
- Decision date
- 1992-06-19
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Linthicum, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| The BAG manual resuscitator and accessories (K251631) | Laerdal Medical AS | 2025-11-24 |
| butterflyBVM (K243861) | Compact Medical, Inc. | 2025-04-25 |
| EOlife® (K221841) | Archeon | 2023-03-18 |
| Sotair Device (K212905) | Safe Bvm Corporation | 2022-08-18 |
| Disposable Manual Resuscitator (K210288) | Xiamen Compower Medical Tech. Co., Ltd. | 2021-08-26 |
| Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 (K181583) | Flexicare Medical Limited. | 2018-12-07 |
| Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (K170663) | Foremount Enterprise Co., Ltd. | 2018-05-11 |
| Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (K152931) | Ambu A/S | 2016-08-29 |
| NEONATALIE RESUSCITATOR (K132172) | Laerdal Medical A/S | 2015-01-15 |
| BABI PLUS NEONATAL RESUSCITATION BAG (K112852) | A Plus Medical | 2012-01-13 |
| AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (K102824) | Ambu A/S | 2011-01-28 |
| NEOPOP INFANT RESUSCITATOR WITH FLOW METER (K102649) | Neoforce Group, Inc. | 2011-01-06 |
Recalls involving this device
No recalls on record reference this clearance.