Volcano Corporation: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Volcano Corporation” (first 2005, latest 2021), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 65 days. Since 2017 the median was 48 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 100 |
| 2013 | 8 | 39 |
| 2014 | 3 | 59 |
| 2015 | 10 | 62 |
| 2016 | 3 | 71 |
| 2017 | 3 | 57 |
| 2018 | 1 | 112 |
| 2019 | 2 | 29 |
| 2020 | 2 | 97 |
| 2021 | 2 | 53 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Volcano Corporation took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 19 | 19 |
| OBJ | Catheter, Ultrasound, Intravascular | 14 | 14 |
| DQX | Wire, Guide, Catheter | 7 | 7 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DTK | Filter, Intravascular, Cardiovascular | 1 | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (30)
- Radiology (24)
- General Hospital (1)
Most recent Volcano Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210235 | Verrata PLUS Pressure Guide Wire | DQX | 2021-04-15 | 77 |
| K203719 | IntraSight Mobile | IYO | 2021-01-19 | 29 |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | 2020-09-28 | 26 |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip | DQX | 2020-03-26 | 168 |
| K190626 | SyncVision System | OWB | 2019-04-12 | 32 |
| K190078 | IntraSight | DSA | 2019-02-11 | 26 |
| 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 | IYO | 2018-04-11 | 112 |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | IYO | 2017-10-25 | 72 |
| K172574 | SyncVision System | OWB | 2017-10-05 | 38 |
| K170385 | CORE M2 Vascular System | IYO | 2017-04-06 | 57 |
45 earlier clearances. See the full list in Caduvo.
Recalls
37 product recalls in 25 recall events; 8 initiated in the last five years. Most recent: 2026-08-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Volcano Corporation is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02475200: Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems (Completed, started 2015-09-14)
- NCT02281110: The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses (Completed, started 2014-07)
- NCT01158053: Vascular Evaluation for Revascularization: Defining the Indications for Coronary Therapy: A Pilot Study (Completed, started 2010-09)
- NCT01153555: Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy (Completed, started 2010-09)
- NCT02316782: Bifurcation Lesion Analysis and STenting / BLAST (Completed, started 2008-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Volcano Atheromed, Inc. (7 510(k)s)
- Volcano Therapeutics, Inc. (3 510(k)s)
- Volcano Corporation (Dba Philips Image Guided Therapy Device (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Volcano Corporation?
FDA lists 55 510(k) clearances under the applicant name “Volcano Corporation” (first 2005, latest 2021), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Volcano Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Volcano Corporation is 65 days. Since 2017: 48 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Volcano Corporation?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 19); OBJ (Catheter, Ultrasound, Intravascular, 14); DQX (Wire, Guide, Catheter, 7).
Next steps
- See all 55 Volcano Corporation clearances with predicates and recalls
- Run predicate analysis for product code IYO, Volcano Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.