510(k) · Cleared

Cleared

NP Medical Capless Luer Activated Valve

K973916510(k) TraditionalCleared Mar 9, 1998146-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

Np Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Mar 9, 1998 as substantially equivalent to K915571 (Icu Medical, Inc., 1992) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.

Decided: Mar 9, 1998
Review: 146 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. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
This deviceK973916 NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998
Descendant · cites it directly · 4 of its ownK072576 Clearlink Antimicrobial Luer Activated Device (Lad) and Extension…Baxter Healthcare Corp · 2007
Descendant · 2 generations on · 3 of its ownK081289 V-Link Antimicrobial Luer Activated Device and Extension Sets with…Baxter Healthcare Corp · 2008
Descendant · 2 generations on · 0 of its ownK103551 Interlink S / Clearlink System / V-Link Lad with Vitalshield…Baxter Healthcare Corp · 2011 · Recalled
Descendant · 3 generations on · 0 of its ownK093489 IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010 · Recalled
Descendant · 2 generations on · 0 of its ownK090189 Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc. · 2009

Most influential descendants

Showing 5 of 5 · See all

K072576Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Baxter Healthcare Corp · 2007 · cites it directly4descendants
K081289V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Baxter Healthcare Corp · 2008 · 2 generations on3descendants
K103551Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp…Baxter Healthcare Corp · 2011 · 2 generations on0descendants
K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010 · 3 generations on0descendants
K090189Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc. · 2009 · 2 generations on0descendants

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)	K973916	NP Medical Capless Luer Activated Valve	Np Medical, Inc.	1998	—
+1	K072576	Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with…	Baxter Healthcare Corp	2007	—
+2	K081289	V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link…	Baxter Healthcare Corp	2008	—
+2	K103551	Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective…	Baxter Healthcare Corp	2011	1
+3	K093489	IN Vision-Plus Nano with Neutral Advantage Technology	Rymed Technologies, Inc.	2010	1
+2	K090189	Antimicrobial Clave, Models AG Clave, AG Microclave	Icu Medical, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K973916, 1992–2011Source: 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
*	K915571	Clave Connector Summary page 1 …VICE: The predicate device used to determine substantial equivalence for the NP Medical Capless Needleless Luer Connector is the ICU Medical Clave Needleless Connector (K915571 / K941190). 4. DEVICE DESCRIPTION: The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly…	Icu Medical, Inc.	1992	3
*	K941190	Clave Needle-Less Connector Open Extension Set Summary page 1 …predicate device used to determine substantial equivalence for the NP Medical Capless Needleless Luer Connector is the ICU Medical Clave Needleless Connector (K915571 / K941190). 4. DEVICE DESCRIPTION: The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gla…	Icu Medical, Inc.	1995	1

Also cleared against K915571: 6 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K072576	Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…	Baxter Healthcare Corp	2007	4

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, K072576 (Baxter Healthcare Corp, 2007) has gone furthest, with 4 descendants of its own.
6 other devices also cite its predicate K915571.

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 Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.

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/K973916 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973916: NP Medical Capless Luer Activated Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973916

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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