510(k) Report

510(k) · Cleared

Cleared

Angiocath (R) Nonvalon (R) and Angio-Set (R) IV Catheters

K950301510(k) TraditionalCleared Apr 18, 199583-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

Becton Dickinson Vascular Access, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Apr 18, 1995 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided
Apr 18, 1995
Review
83 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

17 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2011: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2017: 3 descendants cleared2023: 2 descendants cleared2025: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950301 Angiocath (R) Nonvalon (R) and Angio-Set (R) IV CathetersBecton Dickinson Vascular Access, Inc. · 1995
  2. Descendant · cites it directly · 13 of its ownK111366 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011
  3. Descendant · 2 generations on · 12 of its ownK123734 BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013
  4. Descendant · 3 generations on · 11 of its ownK161777 BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016 · Recalled
  5. Descendant · 4 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
  6. Descendant · 4 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 12013: 12015: 12016: 12017: 32019: 12021: 12023: 22024: 12025: 22026: 1
2008high 3 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all
  • K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011 · cites it directly13descendants
  • K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013 · 2 generations on12descendants
  • K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016 · 3 generations on11descendants
  • K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 4 generations on6descendants
  • K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950301Angiocath (R) Nonvalon (R) and Angio-Set (R) IV CathetersBecton Dickinson Vascular Access, Inc.1995—
+1K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD)2011—
+2K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2013—
+3K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc.20161
+4K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless…Becton, Dickinson and Company2017—
+4K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20193

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201110
201310
201510
201610
201730
201910
202110
202320
202410
202520
202610
FIG. 1 — Lineage of K950301, 1995–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD)201113
K081042Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp.20082

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?

  • Of its descendants, K111366 (Becton, Dickinson and Company (BD), 2011) has gone furthest, with 13 descendants of its own.

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.

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—

More from Becton Dickinson Vascular Access, Inc.

25 FDA decisions under this applicant name. See the company

  • K971339Insyte, Insyte-W, Insyte Autoguard CathetersBecton Dickinson Vascular Access, Inc. · 1997
  • K970259E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
  • K964050First Midcath CatheterBecton Dickinson Vascular Access, Inc. · 1997
  • K964048First Midcath Catheter KitBecton Dickinson Vascular Access, Inc. · 1997
  • K964049First Midcath Catheter with Dual LumensBecton Dickinson Vascular Access, Inc. · 1997

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/K950301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950301: Angiocath (R) Nonvalon (R) and Angio-Set (R) IV Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950301

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026