# K063223: Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jan 23, 2008 after 456 days
- Product code: HDW (Diaphragm, Contraceptive (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.5350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ortho McNeil Diaphragm: named in the summary without a submission number

## Most influential descendants
- K080040: Ortho All-Flex Diaphragm (2008), 1 descendant of its own
- K140305: Caya Contoured Diaphragm (2014), 0 descendants of its own

## Recalls of this device
- Feb 16, 2016 · Class II · Z-1054-2016: The products have been identified to contain an incorrect size Diaphragm.
- May 20, 2015 · Class II · Z-1814-2015: A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
- Feb 26, 2013 · Class II · Z-1018-2013: Incorrect size was printed on the outer product packaging.

## Indications for use
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.

Source page: https://510kreport.com/device/K063223
Methodology: https://510kreport.com/methodology