# K080040: Ortho All-Flex Diaphragm

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Produtos Profissionais Ltda.
- Decided: Aug 25, 2008 after 231 days
- Product code: HDW (Diaphragm, Contraceptive (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.5350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063223 (2008). 1 ancestor in all.
1 later device descends 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)
- K063223: Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms, CooperSurgical, Inc. (2008). Cleared while this submission was under review Summary page 3.
- (no number) ORTH-O® ALL-FLEX® Diaphragm (Latex): named in the summary without a submission number

## Most influential descendants
- K140305: Caya Contoured Diaphragm (2014), 0 descendants of its own

## Indications for use
The ORTHO®ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.

Source page: https://510kreport.com/device/K080040
Methodology: https://510kreport.com/methodology