AIRPURGE
FDA 510(k) clearance DEN080009 · decided 2014-03-04
Clearance details
- K-number
- DEN080009
- Device name
- AIRPURGE
- Applicant
- Anesthesia Safety Products, LLC
- Decision
- Unknown
- Date received
- 2008-10-29
- Decision date
- 2014-03-04
- Days to decision
- 1952 days
- Clearance type
- Post-NSE
- Product code
- OKL
- Device class
- 2
- Regulation number
- 880.5445
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Anesthesia Safety Products
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.
| Record | Firm | Date |
|---|---|---|
| ClearLine IV (K171954) | Clearline MD | 2018-01-25 |
Recalls involving this device
No recalls on record reference this clearance.