Dolphin Inflation Device

510(k) K042449

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK042449	Date18 Apr 2005Cleared	StatusActive

4 recalls · FDA

- Terminated Z-2639-2017 FDA Class II initiated 7 Jun 2017
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
- Terminated Z-2180-2017 FDA Class II initiated 12 Apr 2017
The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection.
- Terminated Z-1891-2017 FDA Class II initiated 5 Apr 2017
Complaints regarding broken blister.
- Terminated Z-0876-2015 FDA Class II initiated 6 Oct 2014
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

1 jurisdiction

United States — FDA 510(k) Active

510(k)