510(k) · Cleared

Cleared

Luer Access Injection Site

K984060510(k) TraditionalCleared Jul 26, 1999255-day reviewClass II21 CFR 880.5440

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

Baxter Healthcare Corp · FPA Set, Administration, Intravascular

Cleared on Jul 26, 1999 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) and 1 other predicate after a 255-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Jul 26, 1999
Review: 255 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K915571 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
This deviceK984060 Luer Access Injection SiteBaxter Healthcare Corp · 1999
Descendant · cites it directly · 0 of its ownK042936 Solution Administration with Luer Access Injection SiteBaxter Healthcare Corp · 2004 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K042936Solution Administration with Luer Access Injection SiteBaxter Healthcare Corp · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915571	Clave Connector	Icu Medical, Inc.	1992	3
0 (this device)	K984060	Luer Access Injection Site	Baxter Healthcare Corp	1999	—
+1	K042936	Solution Administration with Luer Access Injection Site	Baxter Healthcare Corp	2004	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K984060, 1992–2004Source: 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? (2)

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
*	K970855	Clave Connector Summary page 2 …New Device to Predicate Devices The proposed luer access injection site is similar to the currently marketed ICU Medical Inc. Clave™ Needleless Connector, cleared under K970855 and K915571. Both devices are injection ports activated by male luer connectors to allow needleless access to the fluid or vascul…	Icu Medical, Inc.	1997	52
*	K915571	Clave Connector Summary page 2 …o Predicate Devices The proposed luer access injection site is similar to the currently marketed ICU Medical Inc. Clave™ Needleless Connector, cleared under K970855 and K915571. Both devices are injection ports activated by male luer connectors to allow needleless access to the fluid or vascular path. One…	Icu Medical, Inc.	1992	3

Also cleared against K970855: 14 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K042936	Solution Administration with Luer Access Injection Site	Baxter Healthcare Corp	2004	0

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K042936 (Baxter Healthcare Corp, 2004) has gone furthest, with 0 descendants of its own.
14 other devices also cite its predicate K970855.

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 proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.

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/K984060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984060: Luer Access Injection Site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984060

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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