510(k) · Cleared

Recalled · Class II · 2012

Solution Administration with Luer Access Injection Site

K042936510(k) TraditionalCleared Nov 26, 200432-day reviewClass II21 CFR 880.5440Recalls 1

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 Nov 26, 2004 as substantially equivalent to K984060 (Baxter Healthcare Corp, 1999) after a 32-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.

Decided: Nov 26, 2004
Review: 32 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K915571 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
1 generation backK984060 Luer Access Injection SiteBaxter Healthcare Corp · 1999
This deviceK042936 Solution Administration with Luer Access Injection SiteBaxter Healthcare Corp · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K915571	Clave Connector	Icu Medical, Inc.	1992	3
−1	K984060	Luer Access Injection Site	Baxter Healthcare Corp	1999	—
0 (this device)	K042936	Solution Administration with Luer Access Injection Site	Baxter Healthcare Corp	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K042936, 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
*	K984060	Luer Access Injection Site Summary page 2 …functions with similar characteristics to other legally marketed devices such as the Solution Administration Set with Luer Access Injection Site previously cleared under K984060 July 26, 1999. Both are used for solution administration into the vascular system and both are accessed by a standard male luer a…	Baxter Healthcare Corp	1999	—
*	—	Nac PRN Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 14, 2012	Class II	Z-2687-2016	Unknown/Undetermined by firm	Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
2 of the 3 ancestors have a recall of any class.

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?

IV/Catheter Extension Set with NAG Plus Needleless Access Connector is intended to administer drugs and solutions into a patient's vascular system. The NAC Plus (integral or stand-alone) allows the user to administer or withdraw solutions. The NAC Plus Needleless Access Connector, available as a stand-alone accessory or as part of the IV/Catheter Extension set, may aid in the prevention of needlestick injury.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042936 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042936: Solution Administration with Luer Access Injection Site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042936

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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