# HDR: Cap, Cervical

- Device class: 2; regulation: 21 CFR 884.5250; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 267 days (middle half 266–268)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1983: 1
- 1986: 2
- 1987: 7
- 1988: 2
- 1989: 5
- 1990: 6
- 1995: 2
- 2000: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K894432: Modified Ham's F-10 W/Albumin (1989), cited by 2
- K884696: Resubmitted Artificial Insemination Instrument Set (1989), cited by 2
- K993953: Oves Cervical Cap (2000), cited by 2
- K872849: Sperm-Select Additional Indication (1987), cited by 2
- K861188: Sperm Capacitation Medium (1987), cited by 1
- K902694: Coaxial Catheter Set (1990), cited by 1
- K872102: Sperm Washing Medium #9932 (1987), cited by 1
- K894264: KDF-2.3 (1989), cited by 1
- K222969: FERTI-LILY Conception Cup (2023), cited by 1
- K890301: Shepard Intrauterine Insemination Catheter (1989), cited by 1

Source page: https://510kreport.com/product-code/HDR
Data by year (CSV): https://510kreport.com/product-code/HDR.csv