510(k) · Cleared
ClearedScout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout Imaging Catheter Patient T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 14, 1998 as substantially equivalent to K942231 (Cardiovascular Imaging Systems, Inc., 1994) and 3 other predicates after a 231-day review. Its family tree reaches back 1 generation to 1992. 1 of the 37 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it.
- Decided
- Jul 14, 1998
- Review
- 231 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K921879 (1992). 4 ancestors in all. 32 later devices descend from it, 1 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK921879 Cbis Catheter Pull-Back DeviceCardiovascular Imaging Systems, Inc. · 1992
- This deviceK974457 Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ…Hewlett-Packard Co. · 1998
- Descendant · cites it directly · 31 of its ownK050995 Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation · 2005
- Descendant · 2 generations on · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- Descendant · 3 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- Descendant · 4 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 5 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid System2 generations on · 2018
Most influential descendants
Showing 5 of 32 · See all- K050995Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation · 2005 · cites it directly31descendants
- K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · 2 generations on28descendants
- K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 3 generations on25descendants
- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 4 generations on24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921879 | Cbis Catheter Pull-Back Device | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| 0 (this device) | K974457 | Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging… | Hewlett-Packard Co. | 1998 | — |
| +1 | K050995 | Revolution 45 MHZ Rotational Ivus Imaging Catheter | Volcano Corporation | 2005 | — |
| +2 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| +3 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| +4 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +5 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K942231 | Microview II/Microrail II CathetersSummary page 1…ular Catheter 21 CFR 870.1200 74 DQO 3) Identification of Predicate Devices: Manufacturer Device 510(k) Number Boston Scientific MicroView lI/MicroRail If 3.2/30 MHz K942231 Boston Scientific ~ Sonicath 3.5F Uitrasound Imaging Catheter K913890 Boston Scientific ~ Automatic Pullback Device K933517 Bosto… | 1994 |
| * | K913890 | Sonicath (TM) 3.5 F, 20 MHZSummary page 1…evices: Manufacturer Device 510(k) Number Boston Scientific MicroView lI/MicroRail If 3.2/30 MHz K942231 Boston Scientific ~ Sonicath 3.5F Uitrasound Imaging Catheter K913890 Boston Scientific ~ Automatic Pullback Device K933517 Boston Scientific CVIS Catheter Pullback Device K921879 4) Description of… | 1992 |
| * | K933517 | Automatic Pull Back DeviceSummary page 1…entific MicroView lI/MicroRail If 3.2/30 MHz K942231 Boston Scientific ~ Sonicath 3.5F Uitrasound Imaging Catheter K913890 Boston Scientific ~ Automatic Pullback Device K933517 Boston Scientific CVIS Catheter Pullback Device K921879 4) Description of the device or modification being submitted for premar… | 1993 |
| * | K921879 | Cbis Catheter Pull-Back DeviceSummary page 1…ton Scientific ~ Sonicath 3.5F Uitrasound Imaging Catheter K913890 Boston Scientific ~ Automatic Pullback Device K933517 Boston Scientific CVIS Catheter Pullback Device K921879 4) Description of the device or modification being submitted for premark.et approval. . - Functionality: M2440A intravascular… | 1992 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050995 | Revolution 45 MHZ Rotational Ivus Imaging Catheter | 2005 | 31 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 4 ancestors has a recall.
- Of its descendants, K050995 (Volcano Corporation, 2005) has gone furthest, with 31 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Scout catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974457 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974457: Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout Imaging Catheter Patient T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974457
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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