Vitrolife Inc.
San Diego, CA, US
Vitrolife Inc. appears in FDA device records in San Diego, CA. FDA records list 9 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Vitrolife Inc. between 2003 and 2022. The busiest year on record is 2004, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213869 | EmbryoSlide+ ic8 dish | MQK | Substantially Equivalent | |
| K192008 | LaserShot M, NaviLase | MRX | Substantially Equivalent | |
| K182798 | KIDScore D3 | PBH | Substantially Equivalent | |
| K173264 | EmbryoScope+ | MQG | Substantially Equivalent | |
| K150961 | EmbryoSlide Culture Dish | MQK | Substantially Equivalent | |
| K133568 | G-TL | MQL | Substantially Equivalent | |
| K032155 | G-THAWKIT BLAST | MQL | Substantially Equivalent | |
| K032154 | G-FREEZEKIT BLAST | MQL | Substantially Equivalent | |
| K022730 | PERFADEX SOLUTION FOR LUNG PRESERVATION | MSB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009107689 | 3009107689 | Vitrolife A/S | Jens Juuls Vej 16, Viby J Midtjylland 8260 DK | 2026 | |
| 3003843927 | 3003843927 | Vitrolife GmbH | Roedersteinstrasse 6, Landshut Bavaria 84034 DE | 2026 | |
| 2031824 | 3002757762 | Vitrolife Inc. | 4940 Carroll Canyon Rd Ste 100, San Diego, CA 92121 US | 2026 | |
| 3003274090 | 3003274090 | Vitrolife Inc. | 3601 South Inca Street, Englewood, CO 80110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MQGAccessory, Assisted Reproduction
- PBHEmbryo Image Assessment System, Assisted Reproduction
- GHOHemocytometer
- MQKLabware, Assisted Reproduction
- MQLMedia, Reproductive
- QKIMedia, Reproductive, Exempt
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt
- CEPRadioimmunoassay, Luteinizing Hormone
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation
- MRXSystem, Assisted Reproduction Laser
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1448-2015 | SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information. | The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added. | Class II | Terminated | |
| Z-2795-2011 | XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018. | Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain