Nidacon International AB: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Nidacon International AB” (first 1998, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 68 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 | 1 | 303 |
| 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 | 11 | 11 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Nidacon International AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131145 | PROINSERT | MQK | 2014-02-20 | 303 |
| K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 | MQL | 2010-06-15 | 336 |
| K023206 | SPERM CRYOPROTEC | MQL | 2002-11-08 | 44 |
| K022443 | SPERMASSIST | MQL | 2002-08-28 | 34 |
| K011607 | SPERMCATCH | MQL | 2001-08-10 | 78 |
| K012123 | NIDOIL | MQL | 2001-08-03 | 28 |
| K011606 | PURESPERM BUFFER | MQL | 2001-07-12 | 49 |
| K011346 | READYSWIM | MQL | 2001-06-28 | 57 |
| K002630 | PURESPERM WASH | MQL | 2000-11-21 | 90 |
| K002623 | PURESPERM 40 AND PURESPERM 80 | MQL | 2000-11-20 | 89 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nidacon International AB.
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 Nidacon International AB?
FDA lists 12 510(k) clearances under the applicant name “Nidacon International AB” (first 1998, latest 2014), across 2 product codes 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 Nidacon International AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nidacon International AB is 68 days.
Which FDA product codes appear under Nidacon International AB?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 11); MQK (Labware, Assisted Reproduction, 1).
Next steps
- See all 12 Nidacon International AB clearances with predicates and recalls
- Run predicate analysis for product code MQL, Nidacon International AB'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.