# K904774: Inglat-O-Ball

- Pathway: 510(k) (Traditional)
- Applicant: Milex Products, Inc.
- Decided: Dec 7, 1990 after 46 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 25, 2022 · Class II · Z-1631-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Jan 21, 2021 · Class II · Z-1152-2021: The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet
- 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 
- Sep 14, 2015 · Class III · Z-0253-2016: The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not me
- 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/K904774
Methodology: https://510kreport.com/methodology