510(k) · Cleared
Recalled · Class II · 2016Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · HDW Diaphragm, Contraceptive (And Accessories)
Cleared on Jan 23, 2008 after a 456-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 23, 2008
- Review
- 456 days
- Class
- Class II
- Product code
- HDW
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK063223 Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing…CooperSurgical, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK080040 Ortho All-Flex DiaphragmJohnson & Johnson Produtos Profissionais Ltda. · 2008
- Descendant · 2 generations on · 0 of its ownK140305 Caya Contoured DiaphragmKessel Medintim GmbH · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063223 | Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms… | CooperSurgical, Inc. | 2008 | — |
| +1 | K080040 | Ortho All-Flex Diaphragm | Johnson & Johnson Produtos Profissionais Ltda. | 2008 | — |
| +2 | K140305 | Caya Contoured Diaphragm | Kessel Medintim GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ortho McNeil Diaphragm Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080040 | Ortho All-Flex Diaphragm | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2016 | Class II | Z-1054-2016 | Package design/selection | The products have been identified to contain an incorrect size Diaphragm. |
| May 20, 2015 | Class II | Z-1814-2015 | Labeling mix-ups | A diaphragm size 80 labeled box was incorrectly packaged with a size 85. |
| Feb 26, 2013 | Class II | Z-1018-2013 | Packaging | Incorrect size was printed on the outer product packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080040 (Johnson & Johnson Produtos Profissionais Ltda., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HDW devicesHDW Diaphragm, Contraceptive (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HDW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HDW
Too few HDW 510(k)s in any year since 2007 to give a median.
Recalls per year · HDW
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDW
1in 2022
MAUDE reports naming product code HDW, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 13 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Milex Wide-Seal Silicone Diaphragms, in conjunction with an approved spennicidal gel or cream are indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063223: Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063223
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026