510(k) Report

510(k) · Cleared

Cleared

Vascular Pathways Rivs Rapid Intravascular Catheter Start System

K073241510(k) AbbreviatedCleared Feb 8, 200884-day reviewClass II21 CFR 880.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vascular Pathways · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Feb 8, 2008 as substantially equivalent to K984059 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1999) after an 84-day review. Its family tree reaches back 1 generation to 1999. 28 later devices descend from it.

Decided
Feb 8, 2008
Review
84 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K984059 (1999). 28 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2014: 4 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2015: 3 descendants cleared2016: 4 descendants cleared2020: 1 descendant cleared2022: 2 descendants cleared2021: 2 descendants cleared2025: 4 descendants cleared2019: 1 descendant cleared2024: 2 descendants cleared2017: 1 descendant cleared2026: 1 descendant clearedK984059 · Angiocath Autoguard Catheter, Insyte Autoguard Catheter · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 6 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants K984059 · Angiocath Autoguard Catheter, Insyte Autoguard Catheter · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19990+5
  1. Root · 1 generation backK984059 Angiocath Autoguard Catheter, Insyte Autoguard CatheterBd Becton Dickinson Vacutainer Systems Preanalytic · 1999
  2. This deviceK073241 Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemVascular Pathways · 2008
  3. Descendant · cites it directly · 27 of its ownK112347 Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18…Vascular Pathways, Inc. · 2011
  4. Descendant · 2 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
  6. Descendant · 2 generations on · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
  7. Descendant · 4 generations on · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 12014: 42015: 32016: 42017: 12019: 12020: 12021: 22022: 22024: 22025: 42026: 1
2011high 4 (2014) · low 0 (2018)2026

Most influential descendants

Showing 5 of 28 · See all
  • K112347Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeVascular Pathways, Inc. · 2011 · cites it directly27descendants
  • K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 2 generations on19descendants
  • K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 3 generations on12descendants
  • K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · 2 generations on7descendants
  • K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K984059Angiocath Autoguard Catheter, Insyte Autoguard CatheterBd Becton Dickinson Vacutainer Systems Preanalytic1999—
0 (this device)K073241Vascular Pathways Rivs Rapid Intravascular Catheter Start SystemVascular Pathways2008—
+1K112347Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeVascular Pathways, Inc.2011—
+2K121073Powerglide Midline CatheterC.R. Bard, Inc.20121
+3K133856Powerglide Midline CatheterC.R. Bard, Inc.20141
+2K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc.2014—
+4K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201310
201440
201530
201640
201710
201910
202010
202120
202220
202420
202540
202610
FIG. 1 — Lineage of K073241, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K984059Angiocath Autoguard Catheter, Insyte Autoguard Catheter
Summary page 1
…heter is substantially Equivalence equivalent to the Angiocath® Autoguard TM and Insyte® Autoguard TM Conclusion Catheter cleared by the FDA under K984059. The RIVS share the same intended use; operation, access to anatomical sites, safety and…
Bd Becton Dickinson Vacutainer Systems Preanalytic1999—

Also cleared against K984059: 2 other devices →

What descends from it? (28)

See all 28

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112347Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeVascular Pathways, Inc.201127

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?

  • Its one ancestor has no recall.
  • Of its descendants, K112347 (Vascular Pathways, Inc., 2011) has gone furthest, with 27 descendants of its own.
  • 2 other devices also cite its predicate K984059.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

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 as stated in the FDA summary.

Also cleared against K984059

2 other devices cite the same predicate.

  • K131555Medsource IV Safety CatheterMedsource International, LLC · 2014
  • K062108Comcaset Safety IV CatheterPitango Medical, Ltd. · 2006

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K073241 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073241: Vascular Pathways Rivs Rapid Intravascular Catheter Start System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073241

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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