510(k) · Cleared
Recalled · Class II · 2022Inglat-O-Ball
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milex Products, Inc. · HHW Pessary, Vaginal
Cleared on Dec 7, 1990 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 15 times.
- Decided
- Dec 7, 1990
- Review
- 46 days
- Class
- Class II
- Product code
- HHW
- Recalls
- 15
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HHW device
- #1 K253698 Milex™ Incontinence Dish Pessaries; Milex™…score 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1631-2022 | Environmental control | 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 | Process change control | 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 the released print dimensions. |
| Apr 10, 2017 | Class II | Z-2054-2017 | Error in labeling | 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… |
| Sep 14, 2015 | Class III | Z-0253-2016 | Labeling mix-ups | 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 meet the required release specification. |
| Sep 30, 2014 | Class III | Z-0207-2015 | Incorrect or no expiration date | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| Sep 30, 2014 | Class III | Z-0208-2015 | Incorrect or no expiration date | Incorrect expiration date printed on the MILEX PESSARY KIT packaging |
| Feb 26, 2013 | Class III | Z-1004-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1005-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1006-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1007-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1008-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1010-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1012-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1011-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Feb 26, 2013 | Class III | Z-1009-2013 | Packaging process control | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHW
263in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HHW
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHW
39in 2025
MAUDE reports naming product code HHW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 9 | 0 |
| 2014 | 2 | — | 2 | 5 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 401 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 5 | 263 | 0 | 6 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K904774 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904774: Inglat-O-Ball.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904774
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026