HDR · Class II · 21 CFR 884.5250

FDA Product Code HDR: Cap, Cervical

Leading manufacturers include Cook Ob/Gyn, Pharmacia, Inc. and Rosesta Medical BV.

29
Total
29
Cleared
111d
Avg days
1981
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 265d recently vs 106d historically

FDA 510(k) Cleared Cap, Cervical Devices (Product Code HDR)

29 devices
1–24 of 29
Cleared Apr 02, 2025
Béa Applicator (BAP-GB-01)
K242031
Stepone Fertility Ltd (T/A B?a Fertility)
Obstetrics & Gynecology · 265d
Cleared Jun 23, 2023
FERTI-LILY Conception Cup
K222969
Rosesta Medical BV
Obstetrics & Gynecology · 269d
Cleared Mar 21, 2000
OVES CERVICAL CAP
K993953
Veos , Ltd.
Obstetrics & Gynecology · 120d
Cleared May 15, 1995
IMAGYN INTRAUTERINE INSEMINATION DEVICE
K945131
Imagyn Medical, Inc.
Obstetrics & Gynecology · 208d
Cleared May 11, 1995
COOK INSEMINATION CUP
K950714
Cook Urological, Inc.
Obstetrics & Gynecology · 85d
Cleared Oct 05, 1990
MINISPACE(TM) IUI CATHETER
K902171
Pharmacia, Inc.
Obstetrics & Gynecology · 144d
Cleared Aug 28, 1990
COAXIAL CATHETER SET
K902694
Cook Ob/Gyn
Obstetrics & Gynecology · 70d
Cleared Jun 26, 1990
INTRAUTERINE INSEMINATION CATHETERS
K896960
C.R. Bard, Inc.
Obstetrics & Gynecology · 194d
Cleared Apr 13, 1990
SPERM SELECT SYSTEM
K900308
Pharmacia, Inc.
Obstetrics & Gynecology · 81d
Cleared Feb 16, 1990
DGH A-SAN PROBE HOLDER
K900162
Jedmed Instrument Co.
Obstetrics & Gynecology · 35d
Cleared Mar 31, 1989
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301
Cook Ob/Gyn
Obstetrics & Gynecology · 67d
Cleared Sep 28, 1987
SPERM-SELECT ADDITIONAL INDICATION
K872849
Pharmacia, Inc.
Obstetrics & Gynecology · 70d
Cleared Mar 02, 1987
INTRAUTERINE INSEMINATION CATHETER
K870551
Cook Ob/Gyn
Obstetrics & Gynecology · 20d
Cleared Dec 11, 1986
MAKLER CATHETER
K863785
I M, Inc.
Obstetrics & Gynecology · 76d
Cleared Jul 13, 1981
AXISONIC II
K810697
Teknar, Inc.
Obstetrics & Gynecology · 119d

About Product Code HDR - Regulatory Context

510(k) Submission Activity

29 total 510(k) submissions under product code HDR since 1981, with 29 receiving FDA clearance (average review time: 111 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - HDR Product Code

Recent submissions under HDR have taken an average of 265 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.

HDR devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →