# Irvine Scientific

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 16 (1982–2016): 16 510(k) clearances
- Product codes: HDR (9), JJY (4), JJX (1), MFD (1), MQL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 2 (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.: 1 (https://510kreport.com/company/irvine-scientific-sales)

## Firms that cite its devices most
- <Genx> Intl., Inc.: 2 (https://510kreport.com/company/genx-intl)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Vitrolife Sweden AB: 1 (https://510kreport.com/company/vitrolife-sweden)
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)
- Fujifilm Irvine Scientific: 1 (https://510kreport.com/company/fujifilm-irvine-scientific)
- Nidacon International AB: 1 (https://510kreport.com/company/nidacon-international)

## Its most-cited devices
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (2016), cited by 4
- K894432: Modified Ham's F-10 W/Albumin (1989), cited by 2
- K861188: Sperm Capacitation Medium (1987), cited by 1
- K872102: Sperm Washing Medium #9932 (1987), cited by 1

## Recent decisions
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (May 4, 2016)
- K914541: Sperm Maintenance Medium with Glycerol (Feb 3, 1994)
- K900316: Modified Ham's F-10 Medium and Medium-Hepes (Apr 16, 1990)
- K894432: Modified Ham's F-10 W/Albumin (Sep 22, 1989)
- K894405: HTF with Albumin (Catalog NO. 9994) (Sep 22, 1989)
- K874668: Sperm Washing Medium #9983 & Modified #9984 (Mar 31, 1988)
- K872203: Cat. #9972 Refrigeration Medium (Test Yolk Buffer) (Aug 14, 1987)
- K872088: Freezing Medium (Test Yolk Buffer W/Glycerol) (Aug 14, 1987)

Source page: https://510kreport.com/company/irvine-scientific