Vitrolife Sweden AB: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Vitrolife Sweden AB” (first 2000, latest 2025), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 218 days, against 181 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 309 |
| 2013 | 0 | — |
| 2014 | 1 | 324 |
| 2015 | 1 | 257 |
| 2016 | 0 | — |
| 2017 | 2 | 234 |
| 2018 | 0 | — |
| 2019 | 2 | 218 |
| 2020 | 0 | — |
| 2021 | 1 | 228 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 118 |
| 2025 | 1 | 266 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vitrolife Sweden AB took a median 218 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 28 | 28 |
| MQE | Needle, Assisted Reproduction | 3 | 3 |
| MQK | Labware, Assisted Reproduction | 3 | 3 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Vitrolife Sweden AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | MQF | 2025-07-23 | 266 |
| K241662 | Ultrasound Transducer Cover | ITX | 2024-08-30 | 81 |
| K240605 | Ultra RapidWarm Blast | MQL | 2024-08-07 | 156 |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | MQL | 2021-05-14 | 228 |
| K183486 | RapidVit Oocyte, RapidWarm Oocyte | MQL | 2019-07-26 | 221 |
| K181461 | Rapid-i Kit | MQK | 2019-01-04 | 214 |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | MQE | 2017-11-21 | 138 |
| K161970 | Follicle Aspiration Set | MQE | 2017-06-14 | 331 |
| K150950 | FreezeKit Cleave , ThawKit Cleave | MQL | 2015-12-21 | 257 |
| K140207 | RAPID-I KIT | MQK | 2014-12-18 | 324 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vitrolife Sweden 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.
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.
- Vitrolife AB/Scandinavian Ivf Sciences AB (7 510(k)s)
- Vitrolife A/S (4 510(k)s)
- Vitrolife AB (3 510(k)s)
- Vitrolife GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitrolife Sweden AB?
FDA lists 38 510(k) clearances under the applicant name “Vitrolife Sweden AB” (first 2000, latest 2025), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vitrolife Sweden AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitrolife Sweden AB is 154 days. Since 2017: 218 days, versus 181 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vitrolife Sweden AB?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 28); MQE (Needle, Assisted Reproduction, 3); MQK (Labware, Assisted Reproduction, 3).
Next steps
- See all 38 Vitrolife Sweden AB clearances with predicates and recalls
- Run predicate analysis for product code MQL, Vitrolife Sweden 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.