Product Code: HDR FDA class 2 21 CFR 884.5250

Cap, Cervical

Obstetrics/Gynecology

The Cervical Cap is a barrier contraceptive device placed over the cervix to prevent sperm from entering the uterus. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification to demonstrate substantial equivalence prior to marketing. The product code is HDR, regulated under 21 CFR 884.5250, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HDR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HDR
Device Class: FDA class 2
Regulation Number: 884.5250
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242031	Béa Applicator (BAP-GB-01)	Apr 02, 2025	Substantially Equivalent	Stepone Fertility Ltd (T/A Béa Fertility)
K222969	FERTI-LILY Conception Cup	Jun 23, 2023	Substantially Equivalent	Rosesta Medical BV
K993953	OVES CERVICAL CAP	Mar 21, 2000	Unknown	Veos , Ltd.
K945131	IMAGYN INTRAUTERINE INSEMINATION DEVICE	May 15, 1995	Substantially Equivalent	Imagyn Medical, Inc.
K950714	COOK INSEMINATION CUP	May 11, 1995	Substantially Equivalent	Cook Urological, Inc.
K902171	MINISPACE(TM) IUI CATHETER	Oct 05, 1990	Substantially Equivalent	Pharmacia, Inc.
K902694	COAXIAL CATHETER SET	Aug 28, 1990	Substantially Equivalent	Cook Ob/Gyn
K896960	INTRAUTERINE INSEMINATION CATHETERS	Jun 26, 1990	Substantially Equivalent	C.R. Bard, Inc.
K900316	MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES	Apr 16, 1990	Substantially Equivalent	Irvine Scientific
K900308	SPERM SELECT SYSTEM	Apr 13, 1990	Substantially Equivalent	Pharmacia, Inc.
K900162	DGH A-SAN PROBE HOLDER	Feb 16, 1990	Substantially Equivalent	Jedmed Instrument Co.
K894432	MODIFIED HAM'S F-10 W/ALBUMIN	Sep 22, 1989	Substantially Equivalent	Irvine Scientific
K894405	HTF WITH ALBUMIN (CATALOG NO. 9994)	Sep 22, 1989	Substantially Equivalent	Irvine Scientific
K894264	KDF-2.3	Aug 15, 1989	Substantially Equivalent	Unimar, Inc.
K890301	SHEPARD INTRAUTERINE INSEMINATION CATHETER	Mar 31, 1989	Substantially Equivalent	Cook Ob/Gyn
K884696	RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET	Jan 27, 1989	Substantially Equivalent	Laboratoire Ccd C/O Washington Regulatory Services
K881414	CERVICATH	Jun 14, 1988	Substantially Equivalent	Epcom Medical Systems, Inc.
K874668	SPERM WASHING MEDIUM #9983 & MODIFIED #9984	Mar 31, 1988	Substantially Equivalent	Irvine Scientific
K872849	SPERM-SELECT ADDITIONAL INDICATION	Sep 28, 1987	Substantially Equivalent	Pharmacia, Inc.
K872203	CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)	Aug 14, 1987	Substantially Equivalent	Irvine Scientific
K872088	FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)	Aug 14, 1987	Substantially Equivalent	Irvine Scientific
K872102	SPERM WASHING MEDIUM #9932	Jul 16, 1987	Substantially Equivalent	Irvine Scientific
K871577	HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES	Jul 15, 1987	Substantially Equivalent	Irvine Scientific
K870551	INTRAUTERINE INSEMINATION CATHETER	Mar 02, 1987	Substantially Equivalent	Cook Ob/Gyn
K861188	SPERM CAPACITATION MEDIUM	Jan 06, 1987	Substantially Equivalent	Irvine Scientific
K863785	MAKLER CATHETER	Dec 11, 1986	Substantially Equivalent	I M, Inc.
K861305	INTRAUTERINE CATHETER	Dec 11, 1986	Substantially Equivalent	Ram Development
K831669	AXCAN SPERM CUP	Jul 12, 1983	Substantially Equivalent	Axcan Scientific Corp.
K810697	AXISONIC II	Jul 13, 1981	Substantially Equivalent	Teknar, Inc.