# Fujifilm Irvine Scientific

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 5 (2019–2025): 5 510(k) clearances
- Names in FDA's records: Fujifilm Irvine Scientific (4); Fujifilm Irvine Scientific, Inc. (1)
- Product codes: MQL (3), NDS (1), MQK (1)
- 510(k) review time since 2016: median 147 days, against 183 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Invitrogen Corporation: 1 (https://510kreport.com/company/invitrogen)
- Energy Delivery Solutions: 1 (https://510kreport.com/company/energy-delivery-solutions)
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)
- Origio A/S: 1 (https://510kreport.com/company/origio-a-s)
- Irvine Scientific: 1 (https://510kreport.com/company/irvine-scientific)

## Firms that cite its devices most
- Zhejiang Horizon Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-horizon-medical-technology)

## Its most-cited devices
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX (2019), cited by 2

## Recent decisions
- K250445: Fast Warm - NX (Sep 12, 2025)
- K241341: cryo-GO Vitrification Device (Sep 26, 2024)
- K233764: SSS-NX (Serum Substitute Supplement-NX) (Apr 24, 2024)
- K231804: PRIME-XV FreezIS DMSO-Free MD (Nov 9, 2023)
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX (Jun 21, 2019)

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