510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Smartsite Needle Free Valve Administration Sets

K061285510(k) TraditionalCleared Jul 26, 200679-day reviewClass II21 CFR 880.5440Recalls 2

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

Cardinal Health, Alaris Products · FPA Set, Administration, Intravascular

Cleared on Jul 26, 2006 as substantially equivalent to K960280 (Y, 1996) after a 79-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it. It has been recalled 2 times.

Decided
Jul 26, 2006
Review
79 days
Class
Class II
Product code
FPA
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K960280 (1996). 6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2023: 1 descendant cleared2010: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant clearedK960280 · Ivac Needle Free Valve Administration Sets · Y · 1996 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants K960280 · Ivac Needle Free Valve Administration Sets · Y · 1996 · recalled0
  1. Root · 1 generation backK960280 Ivac Needle Free Valve Administration SetsY · 1996 · Recalled
  2. This deviceK061285 Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products · 2006
  3. Descendant · cites it directly · 1 of its ownK103562 Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation · 2011 · Recalled
  4. Descendant · cites it directly · 1 of its ownK090134 Intravenous Power Injector Extension SetC.R. Bard, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK223088 BD SmartSite™ Needle-Free ConnectorCare Fusion · 2023
  6. Descendant · 2 generations on · 0 of its ownK141285 Busse Extension SetBusse Hospital Disposables · 2015
  7. Descendant · cites it directly · 0 of its ownK100576 High Pressure Sets-400 PsiIcu Medical, Inc. · 2010 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 12015: 12023: 1
2009high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K103562Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation · 2011 · cites it directly1descendant
  • K090134Intravenous Power Injector Extension SetC.R. Bard, Inc. · 2009 · cites it directly1descendant
  • K223088BD SmartSite™ Needle-Free ConnectorCare Fusion · 2023 · cites it directly0descendants
  • K141285Busse Extension SetBusse Hospital Disposables · 2015 · 2 generations on0descendants
  • K100576High Pressure Sets-400 PsiIcu Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960280Ivac Needle Free Valve Administration SetsY19967
0 (this device)K061285Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products2006—
+1K103562Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation20111
+1K090134Intravenous Power Injector Extension SetC.R. Bard, Inc.2009—
+1K223088BD SmartSite™ Needle-Free ConnectorCare Fusion2023—
+2K141285Busse Extension SetBusse Hospital Disposables2015—
+1K100576High Pressure Sets-400 PsiIcu Medical, Inc.20108

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201110
201510
202310
FIG. 1 — Lineage of K061285, 1996–2023Source: 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 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
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
*K960280Ivac Needle Free Valve Administration Sets
Summary page 1
…ss II D. Product Code: FPA, Intravascular Administration Set DEVICE DESCRIPTION As originally submitted, the SmartSite Administration Sets (K960280) are intended to be used for IV administration of drugs and fluids, and the specific purpose for the SmartSite Valve is to allow…
Y19967

Also cleared against K960280: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K103562Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation20111
K090134Intravenous Power Injector Extension SetC.R. Bard, Inc.20091
K223088BD SmartSite™ Needle-Free ConnectorCare Fusion20230
K100576High Pressure Sets-400 PsiIcu Medical, Inc.20100

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 2, 2021Class IIZ-2454-2021Process controlNeedle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not…
Aug 2, 2021Class IIZ-2455-2021Process controlNeedle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K103562 (Centurion Medical Products Corporation, 2011) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K960280.

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)—

What is it indicated for?

The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.

Indications for use as stated in the FDA summary.

Also cleared against K960280

3 other devices cite the same predicate.

  • K112073Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless Access Device 'Y'…Rx Devices, LLC · 2012
  • K071400Smartsite StopcockCardinal Health, Alaris Products · 2007
  • K970485Smartsite Access PinIvac Medical Systems · 19973 recalls

More from Cardinal Health, Alaris Products

9 FDA decisions under this applicant name. See the company

  • K071400Smartsite StopcockCardinal Health, Alaris Products · 2007
  • K071108Texium SyringeCardinal Health, Alaris Products · 20071 recall
  • K053049Alaris Safety Male LuerCardinal Health, Alaris Products · 20063 recalls
  • K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
  • K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 200510 Class I recalls

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K061285 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061285: Smartsite Needle Free Valve Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061285

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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