# Vitrolife Sweden AB

- Location (FDA's records): Washington, DC
- FDA decisions: 38 (2000–2025): 38 510(k) clearances
- Product codes: MQL (28), MQE (3), MQK (3), MSB (2), MQF (1), ITX (1)
- 510(k) review time since 2016: median 156 days, against 195 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 27 (12 its own); citations of its devices by later devices: 25 (12 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Irvine Scientific Sales Co., Inc.: 6 (https://510kreport.com/company/irvine-scientific-sales)
- Vitrolife AB: 2 (https://510kreport.com/company/vitrolife)
- Swemed Lab International AB: 2 (https://510kreport.com/company/swemed-lab-international)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)
- Irvine Scientific: 1 (https://510kreport.com/company/irvine-scientific)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- <Genx> Intl., Inc.: 1 (https://510kreport.com/company/genx-intl)
- CIVCO Medical Instruments Co., Inc.: 1 (https://510kreport.com/company/civco-medical-instruments)

## Firms that cite its devices most
- Origio A/S: 2 (https://510kreport.com/company/origio-a-s)
- Irvine Scientific Sales Co., Inc.: 2 (https://510kreport.com/company/irvine-scientific-sales)
- Xvivo Perfusion AB: 2 (https://510kreport.com/company/xvivo-perfusion)
- Kitazato Medical Co., Ltd.: 1 (https://510kreport.com/company/kitazato-medical)
- Vitrolife AB: 1 (https://510kreport.com/company/vitrolife)
- TransMedics, Inc.: 1 (https://510kreport.com/company/transmedics)
- Cryo Bio System: 1 (https://510kreport.com/company/cryo-bio-system)
- Biotech, Inc.: 1 (https://510kreport.com/company/biotech)

## Its most-cited devices
- K000881: Perfadex Solution for Organ Preservation (2001), cited by 3
- K090832: Rapid-I (2009), cited by 3
- K080446: Rapidvit and Rapidwarm Cleave (2008), cited by 3
- K081115: G-Mops G5 Series (2008), cited by 2
- K082727: Follicle Aspiration Set, Reduced Single Lumen (2009), cited by 2
- K021893: G-Mops, Model 10030 (2002), cited by 2

## Recent decisions
- 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) (Jul 23, 2025)
- K241662: Ultrasound Transducer Cover (Aug 30, 2024)
- K240605: Ultra RapidWarm™ Blast (Aug 7, 2024)
- K202862: Gx-IVF, Gx-TL, Gx-MOPS PLUS (May 14, 2021)
- K183486: RapidVit™ Oocyte, RapidWarm™ Oocyte (Jul 26, 2019)
- K181461: Rapid-i™ Kit (Jan 4, 2019)
- K172050: Follicle Aspiration Set, Reduced Single Lumen (Nov 21, 2017)
- K161970: Follicle Aspiration Set (Jun 14, 2017)

Source page: https://510kreport.com/company/vitrolife-sweden