Waterpap Valve
510(k) K110713
Waterpap Valve is a Class II device made by Airways Development, LLC, cleared under FDA 510(k) K110713 on 12 Sep 2011, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110713 | Date12 Sep 2011 | StatusActive |
Official records
- FDA 510(k) database K110713
Recalls
-
- Terminated Z-0552-2016
Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted.
Timeline
- Cleared FDA 510(k) K110713
- Recall initiated FDA recalls Z-0552-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BYE
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5965
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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