510(k) · Cleared

Recalled · Class II · 2020

Clave Needle-Less Connector Open Extension Set

K941190510(k) TraditionalCleared Jan 31, 1995323-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

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

Cleared on Jan 31, 1995 after a 323-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled once.

Decided: Jan 31, 1995
Review: 323 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 0

10 later devices descend from it, 4 citing it directly.

This deviceK941190 Clave Needle-Less Connector Open Extension SetIcu Medical, Inc. · 1995
Descendant · cites it directly · 5 of its ownK973916 NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998
Descendant · 2 generations on · 4 of its ownK072576 Clearlink Antimicrobial Luer Activated Device (Lad) and Extension…Baxter Healthcare Corp · 2007
Descendant · 3 generations on · 3 of its ownK081289 V-Link Antimicrobial Luer Activated Device and Extension Sets with…Baxter Healthcare Corp · 2008
Descendant · cites it directly · 1 of its ownK030246 Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc. · 2003
Descendant · 3 generations on · 0 of its ownK103551 Interlink S / Clearlink System / V-Link Lad with Vitalshield…Baxter Healthcare Corp · 2011 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1998high 3 (2008) · low 0 (1999)2026

Most influential descendants

Showing 5 of 10 · See all

K973916NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998 · cites it directly5descendants
K072576Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Baxter Healthcare Corp · 2007 · 2 generations on4descendants
K081289V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Baxter Healthcare Corp · 2008 · 3 generations on3descendants
K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc. · 2003 · cites it directly1descendant
K103551Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp…Baxter Healthcare Corp · 2011 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K941190	Clave Needle-Less Connector Open Extension Set	Icu Medical, Inc.	1995	—
+1	K973916	NP Medical Capless Luer Activated Valve	Np Medical, Inc.	1998	—
+2	K072576	Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with…	Baxter Healthcare Corp	2007	—
+3	K081289	V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link…	Baxter Healthcare Corp	2008	—
+1	K030246	Victus I.V. Administration Set, Models 27071 and 27072	Victus, Inc.	2003	—
+3	K103551	Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective…	Baxter Healthcare Corp	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	1	0
2007	1	0
2008	3	0
2009	1	0
2010	2	0
2011	1	0

FIG. 1 — Lineage of K941190, 1995–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K973916	NP Medical Capless Luer Activated Valve	Np Medical, Inc.	1998	5
K030246	Victus I.V. Administration Set, Models 27071 and 27072	Victus, Inc.	2003	1
K080007	Graduated Adapter with Clave	Icu Medical, Inc.	2008	0
K080077	Clave Stopcock	Icu Medical, Inc.	2008	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 31, 2020	Class II	Z-0705-2021	Process control	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K973916 (Np Medical, Inc., 1998) has gone furthest, with 5 descendants of its own.

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)	—

https://510kreport.com/device/K941190 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941190: Clave Needle-Less Connector Open Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941190

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026