510(k) · Cleared

Recalled · Class I · 2025

Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets

K112893510(k) SpecialCleared Oct 18, 201115-day reviewClass II21 CFR 880.5440Recalls 8 (1 Class I)

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

Baxter Healthcare Corporation · FPA Set, Administration, Intravascular

Cleared on Oct 18, 2011 as substantially equivalent to K003225 (Baxter Healthcare Corp, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 2 of the 13 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 8 times, including a Class I recall.

Decided: Oct 18, 2011
Review: 15 days
Class: Class II
Product code: FPA
Recalls: 8 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K003225 (2000). 11 later devices descend from it, 5 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
This deviceK112893 Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter…Baxter Healthcare Corporation · 2011
Descendant · cites it directly · 4 of its ownK203609 Intravascular Administration SetsBaxter Healthcare Corporation · 2021 · Recalled
Descendant · cites it directly · 2 of its ownK192366 Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation · 2020
Descendant · 2 generations on · 0 of its ownK243529 Solution Administration SetsBaxter Healthcare Corporation · 2025 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK242339 Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation · 2025
Descendant · 2 generations on · 0 of its ownK221121 Volumat Polyethylene I.V. Administration SetFresenius Kabi · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2014high 3 (2023) · low 0 (2015)2026

Class I recalls in this family

K243529 Solution Administration Sets2 generations on · 2025

Most influential descendants

Showing 5 of 11 · See all

K203609Intravascular Administration SetsBaxter Healthcare Corporation · 2021 · cites it directly4descendants
K192366Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation · 2020 · cites it directly2descendants
K243529Solution Administration SetsBaxter Healthcare Corporation · 2025 · 2 generations on0descendants
K242339Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation · 2025 · 2 generations on0descendants
K221121Volumat Polyethylene I.V. Administration SetFresenius Kabi · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003225	Solution Administration Sets with Capless Luer Activated Valve	Baxter Healthcare Corp	2000	18
0 (this device)	K112893	Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension…	Baxter Healthcare Corporation	2011	—
+1	K203609	Intravascular Administration Sets	Baxter Healthcare Corporation	2021	5
+1	K192366	Intravascular Extension Sets and Accessories	Baxter Healthcare Corporation	2020	—
+2	K243529	Solution Administration Sets	Baxter Healthcare Corporation	2025	Class I
+2	K242339	Intravascular Extension Sets and Accessories	Baxter Healthcare Corporation	2025	—
+2	K221121	Volumat Polyethylene I.V. Administration Set	Fresenius Kabi	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2019	1	0
2020	1	0
2021	2	0
2022	1	0
2023	3	0
2025	2	1

FIG. 1 — Lineage of K112893, 2000–2025Source: 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.

2 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K003225	Solution Administration Sets with Capless Luer Activated Valve Summary page 2 …________________________ _________ 510(k) date Modification to Solution Baxter K003225 October 19, Administration Set with Capped Luer H-ealthcare 2000 Activated Device…	Baxter Healthcare Corp	2000	18

Also cleared against K003225: 4 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K203609	Intravascular Administration Sets	Baxter Healthcare Corporation	2021	4
K192366	Intravascular Extension Sets and Accessories	Baxter Healthcare Corporation	2020	2
K212262	PCA Syringe Sets	Baxter Healthcare Corporation	2022	0
K180739	Clearlink System Solution Set	Baxter Healthcare Corporation	2019	0
K141200	Padi-Lock	Padi-Lock, LLC	2014	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 29, 2025	Class II	Z-0190-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0191-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0197-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0198-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0199-2026	Process control	IV sets may leak.
Aug 9, 2022	Class I	Z-1653-2022	Process design	Firm noted an increase in customer reports of leaks.
Sep 4, 2013	Class II	Z-0099-2014	Under Investigation by firm	The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
Mar 28, 2013	Class II	Z-1271-2013	Packaging process control	Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

The 5 latest of 8 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K243529Solution Administration SetsBaxter Healthcare Corporation · 2025 · 2 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K203609 (Baxter Healthcare Corporation, 2021) has gone furthest, with 4 descendants of its own.
4 other devices also cite its predicate K003225.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters (e.g., syringes or sets) for continuous or intermittent fluid administration or the withdrawal of fluids.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112893 · printed Nov 3, 2026

Cite this page

510(k) Report. “K112893: Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112893

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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