Atlas FDA

HDR

29 FDA 510(k) clearances · Product code

79 daysmedian time to decision
265 days90th percentile
29clearances measured

FDA profile

Official device name
Cap, Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5250
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Béa Applicator (BAP-GB-01) (K242031)Stepone Fertility Ltd (T/A Béa Fertility)2025-04-02
FERTI-LILY Conception Cup (K222969)Rosesta Medical BV2023-06-23
OVES CERVICAL CAP (K993953)Veos , Ltd.2000-03-21
IMAGYN INTRAUTERINE INSEMINATION DEVICE (K945131)Imagyn Medical, Inc.1995-05-15
COOK INSEMINATION CUP (K950714)Cook Urological, Inc.1995-05-11
MINISPACE(TM) IUI CATHETER (K902171)Pharmacia, Inc.1990-10-05
COAXIAL CATHETER SET (K902694)Cook Ob/Gyn1990-08-28
INTRAUTERINE INSEMINATION CATHETERS (K896960)C.R. Bard, Inc.1990-06-26
MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (K900316)Irvine Scientific1990-04-16
SPERM SELECT SYSTEM (K900308)Pharmacia, Inc.1990-04-13
DGH A-SAN PROBE HOLDER (K900162)Jedmed Instrument Co.1990-02-16
MODIFIED HAM'S F-10 W/ALBUMIN (K894432)Irvine Scientific1989-09-22
HTF WITH ALBUMIN (CATALOG NO. 9994) (K894405)Irvine Scientific1989-09-22
KDF-2.3 (K894264)Unimar, Inc.1989-08-15
SHEPARD INTRAUTERINE INSEMINATION CATHETER (K890301)Cook Ob/Gyn1989-03-31
RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET (K884696)Laboratoire Ccd C/O Washington Regulatory Services1989-01-27
CERVICATH (K881414)Epcom Medical Systems, Inc.1988-06-14
SPERM WASHING MEDIUM #9983 & MODIFIED #9984 (K874668)Irvine Scientific1988-03-31
SPERM-SELECT ADDITIONAL INDICATION (K872849)Pharmacia, Inc.1987-09-28
FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) (K872088)Irvine Scientific1987-08-14
CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) (K872203)Irvine Scientific1987-08-14
SPERM WASHING MEDIUM #9932 (K872102)Irvine Scientific1987-07-16
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES (K871577)Irvine Scientific1987-07-15
INTRAUTERINE INSEMINATION CATHETER (K870551)Cook Ob/Gyn1987-03-02
SPERM CAPACITATION MEDIUM (K861188)Irvine Scientific1987-01-06
MAKLER CATHETER (K863785)I M, Inc.1986-12-11
INTRAUTERINE CATHETER (K861305)Ram Development1986-12-11
AXCAN SPERM CUP (K831669)Axcan Scientific Corp.1983-07-12
AXISONIC II (K810697)Teknar, Inc.1981-07-13

Track HDR automatically

Every clearance here is in the API, with alerts when new ones post.