Medicult A/S: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Medicult A/S” (first 2000, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 293 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 26 | 26 |
Review panels
Most recent Medicult A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080172 | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 | MQL | 2008-12-18 | 329 |
| K081639 | ICSI CUMULASE | MQL | 2008-09-19 | 100 |
| K080473 | EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED | MQL | 2008-09-03 | 195 |
| K061309 | EMBRYOASSIST | MQL | 2007-02-08 | 274 |
| K061145 | SPERMSLOW | MQL | 2006-10-02 | 160 |
| K060983 | BIOPSY MEDIUM, MODEL REF 1062 | MQL | 2006-07-28 | 109 |
| K060699 | SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) | MQL | 2006-05-10 | 55 |
| K041284 | MEDICULT IVM SYSTEM | MQL | 2004-11-22 | 193 |
| K030490 | ISM1+, IMS2+, AND UTM+ | MQL | 2003-08-20 | 187 |
| K031486 | BLASTFREEZE AND BLASTTHAW | MQL | 2003-06-27 | 46 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicult A/S.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicult A/S?
FDA lists 26 510(k) clearances under the applicant name “Medicult A/S” (first 2000, latest 2008), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medicult A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicult A/S is 293 days.
Which FDA product codes appear under Medicult A/S?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 26).
Next steps
- See all 26 Medicult A/S clearances with predicates and recalls
- Run predicate analysis for product code MQL, Medicult A/S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.