510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Intravenous Extension Set

K895367510(k) TraditionalCleared Oct 6, 198939-day reviewClass II21 CFR 880.5440Recalls 6

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

Medical Product Specialists · FPA Set, Administration, Intravascular

Cleared on Oct 6, 1989 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 6 times.

Decided
Oct 6, 1989
Review
39 days
Class
Class II
Product code
FPA
Recalls
6
Predicates
0

18 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2014: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2021: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2020: 2 descendants cleared2024: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2023: 2 descendants cleared2019: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK895367 Intravenous Extension SetMedical Product Specialists · 1989
  2. Descendant · cites it directly · 14 of its ownK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
  3. Descendant · 2 generations on · 13 of its ownK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
  4. Descendant · 3 generations on · 8 of its ownK142946 TIVAVelano Vascular, Inc. · 2015
  5. Descendant · 4 generations on · 7 of its ownK152924 TIVA¿Velano Vascular · 2016
  6. Descendant · 5 generations on · 6 of its ownK163508 PIVOVelano Vascular · 2017

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 12013: 12014: 12015: 12016: 12017: 12019: 12020: 22021: 12022: 12023: 22024: 12025: 2
2007high 2 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 18 · See all
  • K072783Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed…Smiths Medical Asd, Inc. · 2007 · cites it directly14descendants
  • K081229Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T WingSmiths Medical Asd, Inc. · 2008 · 2 generations on13descendants
  • K142946TIVAVelano Vascular, Inc. · 2015 · 3 generations on8descendants
  • K152924TIVA¿Velano Vascular · 2016 · 4 generations on7descendants
  • K163508PIVOVelano Vascular · 2017 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895367Intravenous Extension SetMedical Product Specialists1989—
+1K072783Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200…Smiths Medical Asd, Inc.2007—
+2K081229Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G…Smiths Medical Asd, Inc.2008—
+3K142946TIVAVelano Vascular, Inc.2015—
+4K152924TIVA¿Velano Vascular2016—
+5K163508PIVOVelano Vascular2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201010
201310
201410
201510
201610
201710
201910
202020
202110
202210
202320
202410
202520
FIG. 1 — Lineage of K895367, 1989–2025Source: 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 FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K072783Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed…Smiths Medical Asd, Inc.200714
K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141
K103165Blood Sampling SetAcacia, Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 5, 2026Class IIZ-2645-2026Process change controlMay contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
Dec 18, 2009Not classifiedZ-1080-2010Process designSome lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
Dec 18, 2009Not classifiedZ-1077-2010Process designSome lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
Dec 18, 2009Not classifiedZ-1079-2010Process designSome lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
Dec 18, 2009Not classifiedZ-1076-2010Process designSome lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
Dec 18, 2009Not classifiedZ-1078-2010Process designSome lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K072783 (Smiths Medical Asd, Inc., 2007) has gone furthest, with 14 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

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https://510kreport.com/device/K895367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895367: Intravenous Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895367

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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