# Volcano Corporation

- Location (FDA's records): San Diego, CA
- FDA decisions: 55 (2005–2021): 55 510(k) clearances
- Product codes: IYO (19), OBJ (14), DQX (7), OWB (5), DQY (3), DXO (1), DSK (1), DSA (1), DTK (1), MMX (1), KKX (1), QEZ (1)
- 510(k) review time since 2016: median 70 days, against 103 for FDA's reviews in the same codes and years (9 of 13 faster)
- Predicates its devices cite: 98 (51 its own); citations of its devices by later devices: 87 (51 its own)
- Recalls linked to its devices: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Endosonics Corp.: 16 (https://510kreport.com/company/endosonics)
- Jomed, Inc.: 11 (https://510kreport.com/company/jomed)
- Volcano Therapeutics, Inc.: 4 (https://510kreport.com/company/volcano-therapeutics)
- Cardio Metrics, Inc.: 2 (https://510kreport.com/company/cardio-metrics)
- Paieon, Inc.: 1 (https://510kreport.com/company/paieon)
- Hewlett-Packard Co.: 1 (https://510kreport.com/company/hewlett-packard)
- Crux Biomedical: 1 (https://510kreport.com/company/crux-biomedical)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Firms that cite its devices most
- Vein 360, LLC: 4 (https://510kreport.com/company/vein-360)
- Philips Image Guided Therapy Corporation: 4 (https://510kreport.com/company/philips-image-guided-therapy)
- Opsens, Inc.: 3 (https://510kreport.com/company/opsens)
- Innovative Health, LLC: 2 (https://510kreport.com/company/innovative-health)
- Ultrasonix Medical Corporation: 2 (https://510kreport.com/company/ultrasonix-medical)
- Northeast Scientific, Inc.: 2 (https://510kreport.com/company/northeast-scientific)
- St. Jude Medical (Now Abbott Medical): 2 (https://510kreport.com/company/st-jude-medical-now-abbott-medical)
- Conavi Medical, Inc.: 2 (https://510kreport.com/company/conavi-medical)

## Its most-cited devices
- K133323: Volcano Ifr Modality (2014), cited by 6
- K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum (2015), cited by 5
- K061215: Volcano S51 Family of Imaging Systems (2006), cited by 4
- K111395: Primewire Prestige Plus (2011), cited by 4
- K150442: Volcano Visions PV .018 Digital IVUS Catheter (2015), cited by 4
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001 (2005), cited by 4

## Recent decisions
- K210235: Verrata PLUS Pressure Guide Wire (Apr 15, 2021)
- K203719: IntraSight Mobile (Jan 19, 2021)
- K202543: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (Sep 28, 2020)
- K192886: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (Mar 26, 2020)
- K190626: SyncVision System (Apr 12, 2019)
- K190078: IntraSight (Feb 11, 2019)
- K173860: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (Apr 11, 2018)
- K172455: CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (Oct 25, 2017)

Source page: https://510kreport.com/company/volcano