# Irvine Scientific Sales Co., Inc.

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 40 (1997–2017): 40 510(k) clearances
- Product codes: MQL (36), MTW (1), JHG (1), LKF (1), MQH (1)
- 510(k) review time since 2016: median 98 days, against 113 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 25 (10 its own); citations of its devices by later devices: 40 (10 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
- Ackrad Laboratories: 3 (https://510kreport.com/company/ackrad-laboratories)
- Vitrolife Sweden AB: 2 (https://510kreport.com/company/vitrolife-sweden)
- Hana Biologics, Inc.: 1 (https://510kreport.com/company/hana-biologics)
- Sage In-Vitro Fertilization, Inc.: 1 (https://510kreport.com/company/sage-in-vitro-fertilization)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Pharmacia, Inc.: 1 (https://510kreport.com/company/pharmacia)
- Irvine Scientific: 1 (https://510kreport.com/company/irvine-scientific)
- <Genx> Intl., Inc.: 1 (https://510kreport.com/company/genx-intl)

## Firms that cite its devices most
- Vitrolife Sweden AB: 6 (https://510kreport.com/company/vitrolife-sweden)
- Nidacon International AB: 3 (https://510kreport.com/company/nidacon-international)
- Vitrolife AB: 3 (https://510kreport.com/company/vitrolife)
- Kitazato Biopharma Co., Ltd.: 2 (https://510kreport.com/company/kitazato-biopharma)
- Invitrocare, Inc.: 2 (https://510kreport.com/company/invitrocare)
- Kitazato Corporation: 2 (https://510kreport.com/company/kitazato)
- Fertipro NV: 2 (https://510kreport.com/company/fertipro)
- William A. Cook Australia Pty., Ltd.: 1 (https://510kreport.com/company/william-a-cook-australia)

## Its most-cited devices
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit (2006), cited by 7
- K041562: Cryotip (2004), cited by 4
- K121572: Continuous Single Culture Complete (2012), cited by 3
- K983586: HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics), Modified HTG Powder- Hepes (Without Antiboditi (1999), cited by 3
- K000309: Blastocyst Freeze Medium, Blastocyst Thaw Medium (2000), cited by 2
- K991343: PVP (Polyvinylpyrrolidone) (1999), cited by 2

## Recent decisions
- K171224: Arctic Sperm Cryopreservation Medium (Aug 31, 2017)
- K170681: Continuous Single Culture -NX (CSCM-NX) (Jun 8, 2017)
- K170602: Continuous Single Culture-NX Complete (CSCM-NXC) (Jun 7, 2017)
- K121572: Continuous Single Culture Complete (Jul 19, 2012)
- K121128: Multipurpose Handling Medium (Jun 6, 2012)
- K093273: Vit Kit - Freeze and Thaw (Mar 3, 2010)
- K072609: Single Step Medium (Feb 12, 2008)
- K072608: Lyophilized Multiblast Medium Kit (Jan 30, 2008)

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