Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HDR — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
265 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025-04-02 | 265 | 0 |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | 2023-06-23 | 269 | 0 |
| K993953 | OVES CERVICAL CAP | Veos , Ltd. | 2000-03-21 | 120 | 0 |
| K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | 1995-05-15 | 208 | 0 |
| K950714 | COOK INSEMINATION CUP | Cook Urological, Inc. | 1995-05-11 | 85 | 0 |
| K902171 | MINISPACE(TM) IUI CATHETER | Pharmacia, Inc. | 1990-10-05 | 144 | 0 |
| K902694 | COAXIAL CATHETER SET | Cook Ob/Gyn | 1990-08-28 | 70 | 0 |
| K896960 | INTRAUTERINE INSEMINATION CATHETERS | C.R. Bard, Inc. | 1990-06-26 | 194 | 0 |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Irvine Scientific | 1990-04-16 | 83 | 0 |
| K900308 | SPERM SELECT SYSTEM | Pharmacia, Inc. | 1990-04-13 | 81 | 0 |
| K900162 | DGH A-SAN PROBE HOLDER | Jedmed Instrument Co. | 1990-02-16 | 35 | 0 |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | Irvine Scientific | 1989-09-22 | 67 | 0 |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | Irvine Scientific | 1989-09-22 | 67 | 0 |
| K894264 | KDF-2.3 | Unimar, Inc. | 1989-08-15 | 56 | 0 |
| K890301 | SHEPARD INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1989-03-31 | 67 | 0 |
| K884696 | RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET | Laboratoire Ccd C/O Washington Regulatory Services | 1989-01-27 | 79 | 0 |
| K881414 | CERVICATH | Epcom Medical Systems, Inc. | 1988-06-14 | 71 | 0 |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | Irvine Scientific | 1988-03-31 | 139 | 0 |
| K872849 | SPERM-SELECT ADDITIONAL INDICATION | Pharmacia, Inc. | 1987-09-28 | 70 | 0 |
| K872088 | FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) | Irvine Scientific | 1987-08-14 | 74 | 0 |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | Irvine Scientific | 1987-08-14 | 67 | 0 |
| K872102 | SPERM WASHING MEDIUM #9932 | Irvine Scientific | 1987-07-16 | 45 | 0 |
| K871577 | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES | Irvine Scientific | 1987-07-15 | 83 | 0 |
| K870551 | INTRAUTERINE INSEMINATION CATHETER | Cook Ob/Gyn | 1987-03-02 | 20 | 0 |
| K861188 | SPERM CAPACITATION MEDIUM | Irvine Scientific | 1987-01-06 | 281 | 0 |
| K863785 | MAKLER CATHETER | I M, Inc. | 1986-12-11 | 76 | 0 |
| K861305 | INTRAUTERINE CATHETER | Ram Development | 1986-12-11 | 248 | 0 |
| K831669 | AXCAN SPERM CUP | Axcan Scientific Corp. | 1983-07-12 | 50 | 0 |
| K810697 | AXISONIC II | Teknar, Inc. | 1981-07-13 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda