Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicult A/S · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
312 daysmedian FDA review time
428 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080172 | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST | Medicult A/S | 2008-12-18 | 329 | 0 |
| K081639 | ICSI CUMULASE | Medicult A/S | 2008-09-19 | 100 | 0 |
| K080473 | EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED | Medicult A/S | 2008-09-03 | 195 | 0 |
| K061309 | EMBRYOASSIST | Medicult A/S | 2007-02-08 | 274 | 0 |
| K061145 | SPERMSLOW | Medicult A/S | 2006-10-02 | 160 | 0 |
| K060983 | BIOPSY MEDIUM, MODEL REF 1062 | Medicult A/S | 2006-07-28 | 109 | 1 |
| K060699 | SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) | Medicult A/S | 2006-05-10 | 55 | 0 |
| K041284 | MEDICULT IVM SYSTEM | Medicult A/S | 2004-11-22 | 193 | 0 |
| K030490 | ISM1+, IMS2+, AND UTM+ | Medicult A/S | 2003-08-20 | 187 | 0 |
| K031486 | BLASTFREEZE AND BLASTTHAW | Medicult A/S | 2003-06-27 | 46 | 0 |
| K031228 | SYNVITRO HYADASE | Medicult A/S | 2003-06-24 | 67 | 0 |
| K003156 | BLASTASSIST SYSTEM | Medicult A/S | 2001-03-22 | 163 | 0 |
| K003163 | SYNVITRO FLUSH | Medicult A/S | 2001-03-22 | 163 | 0 |
| K003404 | SUPRASPERM SYSTEM | Medicult A/S | 2001-03-22 | 141 | 0 |
| K991279 | MEDI-CULT UNIVERSAL IVF-MEDIUM | Medicult A/S | 2000-07-20 | 463 | 0 |
| K991331 | MEDI-CULT M3 MEDIUM | Medicult A/S | 2000-06-20 | 428 | 0 |
| K991334 | MEDI-CULT HYALURONIDASE; | Medicult A/S | 2000-06-20 | 428 | 0 |
| K991471 | MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATA | Medicult A/S | 2000-05-09 | 391 | 0 |
| K991472 | MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1 | Medicult A/S | 2000-05-09 | 391 | 0 |
| K991332 | MEDI-CULT SPERM PREPARATION - MEDIUM; | Medicult A/S | 2000-05-04 | 381 | 0 |
| K991327 | MEDI-CULT FLUSHING MEDIUM | Medicult A/S | 2000-05-04 | 381 | 0 |
| K991470 | MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATAL | Medicult A/S | 2000-03-07 | 328 | 0 |
| K991335 | MEDI-CULT FREEZING & THAWING PACKS | Medicult A/S | 2000-02-28 | 315 | 0 |
| K991333 | MEDI-CULT SPERM FREEZE MEDIUM | Medicult A/S | 2000-02-28 | 315 | 0 |
| K991330 | MEDI-CULT LIQUID PARAFFIN | Medicult A/S | 2000-02-25 | 312 | 0 |
| K991329 | MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE | Medicult A/S | 2000-02-25 | 312 | 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