# K904026: Inflat-O-Ball

- Pathway: 510(k) (Traditional)
- Applicant: Milex Products, Inc.
- Decided: Oct 10, 1990 after 41 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993308: Mentor Evacare Vaginal Pessaries (1999), 2 descendants of its own
- K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (2026), 0 descendants of its own
- K250438: CooperSurgical Milex® Pessaries (2025), 0 descendants of its own

## Recalls of this device
- Apr 10, 2017 · Class II · Z-2054-2017: 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 
- Feb 9, 2015 · Class II · Z-1239-2015: Incorrect size printed on the Milex Pessary Kit packaging label
- Sep 30, 2014 · Class III · Z-0207-2015: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
- Sep 30, 2014 · Class III · Z-0208-2015: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
- Feb 26, 2013 · Class III · Z-1004-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1005-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1006-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1007-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1008-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1010-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1012-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1011-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Feb 26, 2013 · Class III · Z-1009-2013: Pessary mislabeled outer package may not reflect the size of the product contained in the package

Source page: https://510kreport.com/device/K904026
Methodology: https://510kreport.com/methodology