Origio A/S: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Origio A/S” (first 2010, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 138 days. Since 2017 the median was 92 days, against 196 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CooperCompanies, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 253 |
| 2013 | 0 | — |
| 2014 | 4 | 138 |
| 2015 | 0 | — |
| 2016 | 2 | 200 |
| 2017 | 3 | 128 |
| 2018 | 2 | 70 |
| 2019 | 0 | — |
| 2020 | 1 | 87 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Origio A/S took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 10 | 10 |
| MQK | Labware, Assisted Reproduction | 3 | 3 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Origio A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200815 | VitriGuard | MQK | 2020-06-25 | 87 |
| K180740 | VitriGuard | MQK | 2018-05-04 | 43 |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | MQL | 2018-03-02 | 98 |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | MQL | 2017-10-13 | 84 |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | MQF | 2017-03-09 | 279 |
| K162833 | VitriGuard | MQK | 2017-02-16 | 128 |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | MQL | 2016-07-22 | 253 |
| K152932 | BlastGen | MQL | 2016-02-29 | 147 |
| K140317 | EMBRYOGEN | MQL | 2014-06-16 | 126 |
| K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | MQL | 2014-05-14 | 142 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Origio 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.
Device clinical trials
An industry sponsor named Origio A/S is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00565747: Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF (Completed, started 2007-11)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Origio, Inc. (1 510(k)s)
- Origio A/S, A Coopersurgical Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Origio A/S?
FDA lists 14 510(k) clearances under the applicant name “Origio A/S” (first 2010, latest 2020), across 3 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 Origio A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Origio A/S is 138 days. Since 2017: 92 days, versus 196 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Origio A/S?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 10); MQK (Labware, Assisted Reproduction, 3); MQF (Catheter, Assisted Reproduction, 1).
Next steps
- See all 14 Origio A/S clearances with predicates and recalls
- Run predicate analysis for product code MQL, Origio 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.