Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
FDA 510(k) clearance K152931 · decided 2016-08-29
Clearance details
- K-number
- K152931
- Device name
- Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2015-10-05
- Decision date
- 2016-08-29
- Days to decision
- 329 days
- Clearance type
- Abbreviated
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ballerup, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ambu A/S
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number recall (Z-2181-2025) | Ambu Inc. | 2025-08-13 |