510(k) · Cleared

Recalled · Class II · 2021

Smartsite Access Pin

K970485510(k) TraditionalCleared Apr 21, 199770-day reviewClass II21 CFR 880.5440Recalls 3

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

Ivac Medical Systems · FPA Set, Administration, Intravascular

Cleared on Apr 21, 1997 as substantially equivalent to K960280 (Y, 1996) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1990. 11 later devices descend from it. It has been recalled 3 times.

Decided: Apr 21, 1997
Review: 70 days
Class: Class II
Product code: FPA
Recalls: 3
Predicates: 3

Its longest line of descent runs back 1 generation to K901063 (1990). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK901063 Luer Lock Transfer PinAcacia, Inc. · 1990
This deviceK970485 Smartsite Access PinIvac Medical Systems · 1997
Descendant · cites it directly · 5 of its ownK052790 Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
Descendant · cites it directly · 3 of its ownK002689 Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 2001
Descendant · 2 generations on · 1 of its ownK151963 SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015
Descendant · 2 generations on · 1 of its ownK132863 Smartsite VialshieldYukon Medical, LLC · 2013
Descendant · 3 generations on · 0 of its ownK243486 SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2001high 2 (2012) · low 0 (2002)2026

Most influential descendants

Showing 5 of 11 · See all

K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005 · cites it directly5descendants
K002689Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 2001 · cites it directly3descendants
K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015 · 2 generations on1descendant
K132863Smartsite VialshieldYukon Medical, LLC · 2013 · 2 generations on1descendant
K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901063	Luer Lock Transfer Pin	Acacia, Inc.	1990	—
0 (this device)	K970485	Smartsite Access Pin	Ivac Medical Systems	1997	—
+1	K052790	Smartsite Vented Vial Access Device, Model TBD	Cardinal Health, Alaris Products	2005	—
+1	K002689	Swabsite Swabbable Valve, Model 245000	Quest Medical, Inc.	2001	—
+2	K151963	SmartSite Vented Vial Access Device	Yukon Medical, LLC	2015	—
+2	K132863	Smartsite Vialshield	Yukon Medical, LLC	2013	—
+3	K243486	SmartSiteTM Vented Vial Access Device	Yukon Medical, LLC	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	1	0
2006	1	0
2007	1	0
2012	2	0
2013	1	0
2015	1	0
2017	1	0
2024	2	0

FIG. 1 — Lineage of K970485, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K960280	Ivac Needle Free Valve Administration Sets Summary page 1 …ar Administration Set (2) Transfer Set Classification Names: (1) Intravascular Administration Set (2) L.V. Fluid Transfer Set IVAC Needle Free Valve Administration Set, K960280 ICU Medical, Inc., Piggy Lock Needle Housing, K910546. Acacia, Inc., Luer Lock Transfer Pin, K901063. The SmartSite Access Pin…	Y	1996	7
*	K910546	Piggy Lock Needle Housing Summary page 1 …ames: (1) Intravascular Administration Set (2) L.V. Fluid Transfer Set IVAC Needle Free Valve Administration Set, K960280 ICU Medical, Inc., Piggy Lock Needle Housing, K910546. Acacia, Inc., Luer Lock Transfer Pin, K901063. The SmartSite Access Pin is a stand alone accessory and is the same device as t…	Icu Medical, Inc.	1991	—
*	K901063	Luer Lock Transfer Pin Summary page 1 ….V. Fluid Transfer Set IVAC Needle Free Valve Administration Set, K960280 ICU Medical, Inc., Piggy Lock Needle Housing, K910546. Acacia, Inc., Luer Lock Transfer Pin, K901063. The SmartSite Access Pin is a stand alone accessory and is the same device as the currently marketed IVAC Needle Free Valve (K9…	Acacia, Inc.	1990	—

Also cleared against K960280: 3 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K052790	Smartsite Vented Vial Access Device, Model TBD	Cardinal Health, Alaris Products	2005	5
K002689	Swabsite Swabbable Valve, Model 245000	Quest Medical, Inc.	2001	3
K233021	BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device	Care Fusion	2024	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 2, 2021	Class II	Z-2461-2021	Process control	Needle-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, 2021	Class II	Z-2468-2021	Process control	Needle-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…
Nov 17, 2016	Class II	Z-1883-2017	Other	CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K052790 (Cardinal Health, Alaris Products, 2005) has gone furthest, with 5 descendants 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

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.

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

https://510kreport.com/device/K970485 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970485: Smartsite Access Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970485

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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