510(k) Report

510(k) · Cleared

Cleared

Vitaflon Plus/Vasculon

K941417510(k) TraditionalCleared Oct 6, 1994197-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

Hogan & Hartson · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Oct 6, 1994 as substantially equivalent to K883415 (Ohmeda Medical, 1988) and 4 other predicates after a 197-day review. Its family tree reaches back 1 generation to 1985.

Decided
Oct 6, 1994
Review
197 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K853701 (1985). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestorK853701 · Jelco & Cathlon IV Striped IV Catheters-Radiopagul · Critikon Company, LLC · 1985198619881990199219941996
Other ancestors, by generation 1 generation back: 4 other ancestors K853701 · Jelco & Cathlon IV Striped IV Catheters-Radiopagul · Critikon Company, LLC · 19850
  1. Root · 1 generation backK853701 Jelco & Cathlon IV Striped IV Catheters-RadiopagulCritikon Company, LLC · 1985
  2. This deviceK941417 Vitaflon Plus/VasculonHogan & Hartson · 1994
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K853701Jelco & Cathlon IV Striped IV Catheters-RadiopagulCritikon Company, LLC1985—
0 (this device)K941417Vitaflon Plus/VasculonHogan & Hartson1994—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198810
198910
199210
FIG. 1 — Lineage of K941417, 1985–1994Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (5)

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
*K883415Vasculon 2 Intravenous Cannula
Summary page 1
510 (K) SUMMARY The Vitaflon™ Plus/VasculonPlus® intravascular catheters are substantially equivalent in design to the Vasculon 2 Intravenous cannula (K883415), the Critikon (Johnson & Johnson company), Optically Clear Radiopaque Catheter (Optiva) (K893546), JELCO™ catheter (K853701) and…
Ohmeda Medical1988—
*K893546Optically Clear Radiopaque Catheter
Summary page 1
…bstantially equivalent in design to the Vasculon 2 Intravenous cannula (K883415), the Critikon (Johnson & Johnson company), Optically Clear Radiopaque Catheter (Optiva) (K893546), JELCO™ catheter (K853701) and the Becton-Dickinson Insyte Artcath Arterial Catheterization Unit (K921845). These catheters are…
Critikon Company, LLC1989—
*K853701Jelco & Cathlon IV Striped IV Catheters-Radiopagul
Summary page 1
…esign to the Vasculon 2 Intravenous cannula (K883415), the Critikon (Johnson & Johnson company), Optically Clear Radiopaque Catheter (Optiva) (K893546), JELCO™ catheter (K853701) and the Becton-Dickinson Insyte Artcath Arterial Catheterization Unit (K921845). These catheters are for the same intended use…
Critikon Company, LLC1985—
*K921845Insyte Artcath Arterial Catheterization Unit
Summary page 1
…ohnson company), Optically Clear Radiopaque Catheter (Optiva) (K893546), JELCO™ catheter (K853701) and the Becton-Dickinson Insyte Artcath Arterial Catheterization Unit (K921845). These catheters are for the same intended use and function and are indicated to gain access to the peripheral vein of the blo…
Becton Dickinson Vascular Access, Inc.1992—
*K851293Implantofix
Summary page 1
…ous therapy, blood transfusion and pressure monitoring. The Vitaflon/Vasculon Plus catheter is substantially equivalent in catheter material to the Burron Implantofix (K851293), the Optiva (K893546) Criticon and the Insyte (K921845) B & D. Y1 mvices r"uun.é DEPARTMENT OF HEALTH & HUMAN…
Burron Medical Products, Inc.1986—

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?

  • None of the 5 ancestors has a recall.

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—

What is it indicated for?

These catheters are for the same intended use and function and are indicated to gain access to the peripheral vein of the blood system for intravenous therapy, blood transfusion and pressure monitoring.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Hogan & Hartson

26 FDA decisions under this applicant name. See the company

  • K974168Coopersurgical Infrared CoagulatorHogan & Hartson · 1998
  • K973849Bioabsorbable Bankart TackHogan & Hartson · 1998
  • K973162Dual Radiation Targeting System DRTS DrapeHogan & Hartson · 1997
  • K950169Ribosomal P Eia Test SystemHogan & Hartson · 1996
  • K942389Trocars, Trocar Sleeves and Reduction SleevesHogan & Hartson · 1996

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/K941417 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941417: Vitaflon Plus/Vasculon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941417

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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