# Medicult A/S

- Location (FDA's records): San Diego, CA
- FDA decisions: 26 (2000–2008): 26 510(k) clearances
- Product codes: MQL (26)
- Predicates its devices cite: 17 (12 its own); citations of its devices by later devices: 22 (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
- Vitrolife AB/Scandinavian Ivf Sciences AB: 2 (https://510kreport.com/company/vitrolife-ab-scandinavian-ivf-sciences)
- Halozyme Therapeutics, Inc.: 1 (https://510kreport.com/company/halozyme-therapeutics)
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)
- Cook Ob/Gyn: 1 (https://510kreport.com/company/cook-ob-gyn)

## Firms that cite its devices most
- Origio A/S: 4 (https://510kreport.com/company/origio-a-s)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)
- Artsmedia Denmark Aps: 1 (https://510kreport.com/company/artsmedia-denmark)
- Nidacon International AB: 1 (https://510kreport.com/company/nidacon-international)
- Halozyme Therapeutics, Inc.: 1 (https://510kreport.com/company/halozyme-therapeutics)
- Sage In-Vitro Fertilization, Inc.: 1 (https://510kreport.com/company/sage-in-vitro-fertilization)
- Origio A/S, A Coopersurgical Company: 1 (https://510kreport.com/company/origio-a-s-a-coopersurgical)

## Its most-cited devices
- K991279: Medi-Cult Universal Ivf-Medium (2000), cited by 3
- K031228: Synvitro Hyadase (2003), cited by 2
- K003156: Blastassist System (2001), cited by 2
- K991334: Medi-Cult Hyaluronidase; (2000), cited by 2
- K080172: Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216 (2008), cited by 1
- K080473: Embryoassist and Embryoassist with Phenol Red (2008), cited by 1

## Recent decisions
- K080172: Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216 (Dec 18, 2008)
- K081639: Icsi Cumulase (Sep 19, 2008)
- K080473: Embryoassist and Embryoassist with Phenol Red (Sep 3, 2008)
- K061309: Embryoassist (Feb 8, 2007)
- K061145: Spermslow (Oct 2, 2006)
- K060983: Biopsy Medium, Model Ref 1062 (Jul 28, 2006)
- K060699: Synvitro Cumulase (Hyaluronidase Medium) (May 10, 2006)
- K041284: Medicult Ivm System (Nov 22, 2004)

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