510(k) Report

510(k) · Cleared

Cleared

BD Nexiva Diffusics Closed IV Catheter System

K111366510(k) TraditionalCleared Sep 30, 2011137-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 and Company (BD) · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Sep 30, 2011 as substantially equivalent to K102520 (Becton Dickinson Infusion Therapy Systems, Inc., 2011) and 2 other predicates after a 137-day review. Its family tree reaches back 2 generations to 2004. 13 later devices descend from it.

Decided
Sep 30, 2011
Review
137 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K032843 (2004). 3 ancestors in all, the oldest K950301 (1995). 13 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2013: 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 clearedK032843 · Nexiva Closed IV Catheter System · Becton Dickinson Infusion Therapy Systems, Inc. · 2004 · recalledK102520 · BD Nexiva Closed IV Catheter System · Becton Dickinson Infusion Therapy Systems, Inc. · 20111995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants K102520 · BD Nexiva Closed IV Catheter System · Becton Dickinson Infusion Therapy Systems, Inc. · 2011K032843 · Nexiva Closed IV Catheter System · Becton Dickinson Infusion Therapy Systems, Inc. · 2004 · recalled0+5
  1. Root · 2 generations backK032843 Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2004 · Recalled
  2. 1 generation backK102520 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011
  3. This deviceK111366 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011
  4. Descendant · cites it directly · 12 of its ownK123734 BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013
  5. Descendant · 2 generations on · 11 of its ownK161777 BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016 · Recalled
  6. Descendant · 3 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
  7. Descendant · 3 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
  8. Descendant · 3 generations on · 3 of its ownK170283 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 12016: 12017: 32019: 12021: 12023: 22024: 12025: 22026: 1
2013high 3 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 13 · See all
  • K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013 · cites it directly12descendants
  • K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016 · 2 generations on11descendants
  • K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 3 generations on6descendants
  • K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 3 generations on5descendants
  • K170283BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company · 2017 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K032843Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.200417
−1K102520BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2011—
0 (this device)K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD)2011—
+1K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2013—
+2K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc.20161
+3K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless…Becton, Dickinson and Company2017—
+3K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20193
+3K170283BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201610
201730
201910
202110
202320
202410
202520
202610
FIG. 1 — Lineage of K111366, 2004–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K102520BD Nexiva Closed IV Catheter System
Summary page 1
…Reference: 21 CFR 880.5200 - Class 11 Classification Panel: General Hospital Premarket Notification: Special 510(k) K102520, Traditional 510(k) K032843 Trade Name: BD Angiocath IV Cat…
Becton Dickinson Infusion Therapy Systems, Inc.2011—
*K032843Nexiva Closed IV Catheter System
Summary page 1
…ification Panel: General Hospital Premarket Notification: Special 510(k) K102520, Traditional 510(k) K032843 Trade Name: BD Angiocath IV Catheter with Sideholes Common Name: Periphe…
Becton Dickinson Infusion Therapy Systems, Inc.200417
*K950301Angiocath (R) Nonvalon (R) and Angio-Set (R) IV Catheters
Summary page 1
…travascular Catheter CFR Reference: 880.5200 Classification Panel: General Hospital Premarket Notifications: K950301 (was a preamendment device before clearance under this 51 0(k) for a revised…
Becton Dickinson Vascular Access, Inc.1995—

Also cleared against K102520: 6 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201312

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 7 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K123734 (Becton Dickinson Infusion Therapy Systems, Inc., 2013) has gone furthest, with 12 descendants of its own.
  • 6 other devices also cite its predicate K102520.

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. 2011, 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 BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patients vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

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

Also cleared against K102520

6 other devices cite the same predicate.

  • K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd. · 2025
  • K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. · 2023
  • K171530Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa · 20173 recalls
  • K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 20161 recall
  • K121488JMS Safe Wing Cath (SWC)JMS North America Corporation · 2013
  • K121073Powerglide Midline CatheterC.R. Bard, Inc. · 20121 recall

More from Becton, Dickinson and Company (BD)

5 FDA decisions under this applicant name. See the company

  • K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
  • K112586Ceftaroline 30 Micrograms, BBL (TM) Sensi-Disc (TM)Becton, Dickinson and Company (BD) · 20111 recall
  • K110105BD Pen NeedleBecton, Dickinson and Company (BD) · 2011
  • K091292BD Vacutainer Rapid Serum Tube Plus Blood Collection Tube, Model 368771Becton, Dickinson and Company (BD) · 2009

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/K111366 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111366: BD Nexiva Diffusics Closed IV Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111366

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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