510(k) · Cleared
ClearedRapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Pathways, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Sep 22, 2011 as substantially equivalent to K073241 (Vascular Pathways, 2008) after a 38-day review. Its family tree reaches back 2 generations to 1999. 27 later devices descend from it.
- Decided
- Sep 22, 2011
- Review
- 38 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984059 (1999). 27 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK984059 Angiocath Autoguard Catheter, Insyte Autoguard CatheterBd Becton Dickinson Vacutainer Systems Preanalytic · 1999
- 1 generation backK073241 Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemVascular Pathways · 2008
- This deviceK112347 Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18…Vascular Pathways, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- Descendant · cites it directly · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · cites it directly19descendants
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 2 generations on12descendants
- K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · cites it directly7descendants
- K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 3 generations on5descendants
- K153298AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984059 | Angiocath Autoguard Catheter, Insyte Autoguard Catheter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999 | — |
| −1 | K073241 | Vascular Pathways Rivs Rapid Intravascular Catheter Start System | Vascular Pathways | 2008 | — |
| 0 (this device) | K112347 | Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge | Vascular Pathways, Inc. | 2011 | — |
| +1 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| +2 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| +1 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| +3 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +2 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K073241 | Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemSummary page 1…880.5200 Predicate Device: The RIVS 18, 20 and 22 gauge devices are substantially equivalent in intended use and method of operation to the following predicate device: K073241 - Vascular Pathways, Inc., Rapid Intravascular Catheter Start System Device Description: The RJVS 18, 20 and 22 Gauge devices a… | 2008 |
What descends from it? (27)
See all 273 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121073 (C.R. Bard, Inc., 2012) has gone furthest, with 19 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
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/K112347 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112347: Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112347
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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