# Origio A/S

- Location (FDA's records): Måløv, DK
- FDA decisions: 14 (2010–2020): 14 510(k) clearances
- Product codes: MQL (10), MQK (3), MQF (1)
- 510(k) review time since 2016: median 123 days, against 162 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 15 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medicult A/S: 4 (https://510kreport.com/company/medicult-a-s)
- Vitrolife Sweden AB: 2 (https://510kreport.com/company/vitrolife-sweden)
- Portex, Inc.: 1 (https://510kreport.com/company/portex)
- Cook Ob/Gyn: 1 (https://510kreport.com/company/cook-ob-gyn)
- <Genx> Intl., Inc.: 1 (https://510kreport.com/company/genx-intl)
- Biotech, Inc.: 1 (https://510kreport.com/company/biotech)
- Sage Biopharma: 1 (https://510kreport.com/company/sage-biopharma)

## Firms that cite its devices most
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Vitromed GmbH: 1 (https://510kreport.com/company/vitromed)
- Artsmedia Denmark Aps: 1 (https://510kreport.com/company/artsmedia-denmark)
- Fujifilm Irvine Scientific: 1 (https://510kreport.com/company/fujifilm-irvine-scientific)

## Its most-cited devices
- K200815: VitriGuard (2020), cited by 2
- K133707: Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements (2014), cited by 2
- K153267: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash (2016), cited by 1
- K133387: Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red (2014), cited by 1
- K120136: Embryogen (2012), cited by 1
- K162833: VitriGuard (2017), cited by 1

## Recent decisions
- K200815: VitriGuard (Jun 25, 2020)
- K180740: VitriGuard (May 4, 2018)
- K173624: ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) (Mar 2, 2018)
- K172197: SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (Oct 13, 2017)
- K161547: Transem and EchoGen Embryo Transfer Catheters (Mar 9, 2017)
- K162833: VitriGuard (Feb 16, 2017)
- K153267: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash (Jul 22, 2016)
- K152932: BlastGen (Feb 29, 2016)

Source page: https://510kreport.com/company/origio-a-s