Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5250](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5250) → HDR — Cap, Cervical # HDR · Cap, Cervical _Obstetrics/Gynecology · 21 CFR 884.5250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR ## Overview - **Product Code:** HDR - **Device Name:** Cap, Cervical - **Regulation:** [21 CFR 884.5250](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5250) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242031](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K242031.md) | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | Apr 2, 2025 | SESE | | [K222969](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K222969.md) | FERTI-LILY Conception Cup | Rosesta Medical BV | Jun 23, 2023 | SESE | | [K993953](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K993953.md) | OVES CERVICAL CAP | Veos , Ltd. | Mar 21, 2000 | SESU | | [K945131](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K945131.md) | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | May 15, 1995 | SESE | | [K950714](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K950714.md) | COOK INSEMINATION CUP | Cook Urological, Inc. | May 11, 1995 | SESE | | [K902171](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K902171.md) | MINISPACE(TM) IUI CATHETER | Pharmacia, Inc. | Oct 5, 1990 | SESE | | [K902694](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K902694.md) | COAXIAL CATHETER SET | Cook Ob/Gyn | Aug 28, 1990 | SESE | | [K896960](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K896960.md) | INTRAUTERINE INSEMINATION CATHETERS | C.R. Bard, Inc. | Jun 26, 1990 | SESE | | [K900316](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K900316.md) | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Irvine Scientific | Apr 16, 1990 | SESE | | [K900308](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K900308.md) | SPERM SELECT SYSTEM | Pharmacia, Inc. | Apr 13, 1990 | SESE | | [K900162](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K900162.md) | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | Feb 16, 1990 | SESE | | [K894432](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K894432.md) | MODIFIED HAM'S F-10 W/ALBUMIN | Irvine Scientific | Sep 22, 1989 | SESE | | [K894405](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K894405.md) | HTF WITH ALBUMIN (CATALOG NO. 9994) | Irvine Scientific | Sep 22, 1989 | SESE | | [K894264](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K894264.md) | KDF-2.3 | Unimar, Inc. | Aug 15, 1989 | SESE | | [K890301](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K890301.md) | SHEPARD INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | Mar 31, 1989 | SESE | | [K884696](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K884696.md) | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | Laboratoire Ccd C/O Washington Regulatory Services | Jan 27, 1989 | SESE | | [K881414](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K881414.md) | CERVICATH | Epcom Medical Systems, Inc. | Jun 14, 1988 | SESE | | [K874668](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K874668.md) | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | Irvine Scientific | Mar 31, 1988 | SESE | | [K872849](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K872849.md) | SPERM-SELECT ADDITIONAL INDICATION | Pharmacia, Inc. | Sep 28, 1987 | SESE | | [K872203](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K872203.md) | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | Irvine Scientific | Aug 14, 1987 | SESE | ## Top Applicants - Irvine Scientific — 9 clearances - Cook Ob/Gyn — 3 clearances - Pharmacia, Inc. — 3 clearances - Axcan Scientific Corp. — 1 clearance - C.R. Bard, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com