Inflat-O-Ball

510(k) K904026

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

13 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK904026	Date10 Oct 1990Cleared	StatusActive

13 recalls · FDA

- Terminated Z-2054-2017 FDA Class II initiated 10 Apr 2017
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
- Terminated Z-1239-2015 FDA Class II initiated 9 Feb 2015
Incorrect size printed on the Milex Pessary Kit packaging label
2 recalls, same reason
- Terminated Z-0208-2015 FDA Class III initiated 30 Sep 2014
- Terminated Z-0207-2015 FDA Class III initiated 30 Sep 2014
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
9 recalls, same reason
- Terminated Z-1008-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1011-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1004-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1007-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1012-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1005-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1010-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1006-2013 FDA Class III initiated 26 Feb 2013
- Terminated Z-1009-2013 FDA Class III initiated 26 Feb 2013
Pessary mislabeled outer package may not reflect the size of the product contained in the package

1 jurisdiction

United States — FDA 510(k) Active

510(k)