510(k) · Cleared
ClearedVolcano Preview Forward-Looking Ivus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · DQY Catheter, Percutaneous
Cleared on Sep 27, 2013 as substantially equivalent to K122826 (Volcano Corporation, 2013) and 1 other predicate after a 32-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Sep 27, 2013
- Review
- 32 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K934139 (1995). 51 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 6 generations between
- 3 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 2 generations backK113486 Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation · 2012
- 1 generation backK122826 Preview Forward-Looking Ivus Catheter and Laptop System; Preview…Volcano Corporation · 2013
- This deviceK132659 Volcano Preview Forward-Looking Ivus SystemVolcano Corporation · 2013
Show all 10 generations
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 9 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 8 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 7 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 6 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 5 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 4 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 3 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 2 generations backK113486 Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation · 2012
- 1 generation backK122826 Preview Forward-Looking Ivus Catheter and Laptop System; Preview…Volcano Corporation · 2013
- This deviceK132659 Volcano Preview Forward-Looking Ivus SystemVolcano Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −9 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −8 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −7 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −6 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −5 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −4 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −3 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| −2 | K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure System | Volcano Corporation | 2012 | — |
| −1 | K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter… | Volcano Corporation | 2013 | — |
| 0 (this device) | K132659 | Volcano Preview Forward-Looking Ivus System | Volcano Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Summary page 1…ic Intravascular Catheter, 11, OBJ PREDICATE DEVICE: PreV jew®' Forward-Looking IV US Catheter and Laptop System (K 122826) Volcano s5TM/ 5 j Intravascular Ultrasound Imaging and P… | 2013 |
| * | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemSummary page 1…System (K 122826) Volcano s5TM/ 5 j Intravascular Ultrasound Imaging and Pressure System (K 123898) DEVICE DESCRIPTION: The PreView® Forward-Looking I VUS System consists of t… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 51 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The PreViews' Forward-Looking IVUS System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional…
Read the full statement (128 words)
The PreViews' Forward-Looking IVUS System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.0 14" guidewire lumens. The Previews Forward-Looking IVUS System is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.
The PreView® Forward-Looking IVUS System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132659: Volcano Preview Forward-Looking Ivus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132659
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026