510(k) · Cleared
ClearedProvisio™ SLT IVUS™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Provisio Medical, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Apr 23, 2024 as substantially equivalent to K200410 (Philips Image Guided Therapy Corporation, 2020) and 2 other predicates after a 131-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Apr 23, 2024
- Review
- 131 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K934139 (1995). 70 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 9 generations between
- 3 generations backK150441 Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015
- 2 generations backK170133 FFR V2.5Philips Volcano · 2017 · Recalled
- 1 generation backK173860 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i…Volcano Corporation · 2018
- This deviceK233948 Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 12 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 11 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 10 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 9 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 8 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 7 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 6 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 5 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 4 generations backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- 3 generations backK150441 Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015
- 2 generations backK170133 FFR V2.5Philips Volcano · 2017 · Recalled
- 1 generation backK173860 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i…Volcano Corporation · 2018
- This deviceK233948 Provisio™ SLT IVUS™ SystemProvisio Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −12 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −11 | 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 | — |
| −10 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −9 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −8 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −7 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −6 | 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 |
| −4 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| −3 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | — |
| −2 | K170133 | FFR V2.5 | Philips Volcano | 2017 | 1 |
| −1 | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular… | Volcano Corporation | 2018 | — |
| 0 (this device) | K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2020 | 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K200410 | Reconnaissance PV .018 OTW Digital IVUS CatheterSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200410 Reconnaissance PV .018 OTW Digital IVUS Catheter OBJ K092396 Quick-Cross Extreme S… | 2020 |
| * | K092396 | Spectranetics Quick Cross Extreme Support CathetersSummary page 5…Predicate Trade Name (Primary Predicate is listed first) Product Code K200410 Reconnaissance PV .018 OTW Digital IVUS Catheter OBJ K092396 Quick-Cross Extreme Support Catheters DQY K173860 s5/s5i/CORE/CORE Mobi… | 2009 |
| * | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Summary page 5…Reconnaissance PV .018 OTW Digital IVUS Catheter OBJ K092396 Quick-Cross Extreme Support Catheters DQY K173860 s5/s5i/CORE/CORE Mobile Precision Guided Therapy IYO System Device Descrip… | 2018 |
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 29 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 70 ancestors have a recall of any class.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The Provisio™ SLT IVUS™ System is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature.
The Provisio™ SLT IVUS™ System is designed for use as an adjunct to conventional angiographic procedures to evaluate the vessel lumen and provide dimensional measurements.
The SLT IVUS™ Support Crossing Catheter also guides and supports a guidewire during access of the vasculature and provides a conduit for the delivery of saline solutions or radiopaque contrast agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233948: Provisio™ SLT 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/K233948
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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