510(k) · Cleared

Recalled · Class II · 2025

Clearlink System Solution Set

K180739510(k) TraditionalCleared May 28, 2019432-day reviewClass II21 CFR 880.5440Recalls 6

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 May 28, 2019 as substantially equivalent to K112893 (Baxter Healthcare Corporation, 2011) after a 432-day review. Its family tree reaches back 2 generations to 2000. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 6 times.

Decided: May 28, 2019
Review: 432 days
Class: Class II
Product code: FPA
Recalls: 6
Predicates: 1

Its longest line of descent runs back 2 generations to K003225 (2000). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
1 generation backK112893 Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter…Baxter Healthcare Corporation · 2011 · Recalled (Class I)
This deviceK180739 Clearlink System Solution SetBaxter Healthcare Corporation · 2019

Class I recalls in this family

K112893 Clearlink Luer Activated Valve, Clearlink System…direct predicate · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003225	Solution Administration Sets with Capless Luer Activated Valve	Baxter Healthcare Corp	2000	18
−1	K112893	Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension…	Baxter Healthcare Corporation	2011	Class I
0 (this device)	K180739	Clearlink System Solution Set	Baxter Healthcare Corporation	2019	—

FIG. 1 — Lineage of K180739, 2000–2019Source: 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.

1 device in this family has 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

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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
*	K112893	Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets Summary page 5 …Company Predicate 510(k) Clearance Date Clearlink Luer Activated Valve, Clearlink System Baxter Healthcare Corporation K112893 October 18, 2011 Non-DEHP Catheter Extension Sets REASON FOR SUBMISSION: The changes identified as…	Baxter Healthcare Corporation	2011	Class I

Also cleared against K112893: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 29, 2025	Class II	Z-0201-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0203-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0202-2026	Process control	IV sets may leak.
Dec 20, 2024	Class II	Z-1010-2025	Process control	Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Dec 20, 2024	Class II	Z-1009-2025	Process control	Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Feb 8, 2024	Class II	Z-1291-2024	Under Investigation by firm	Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

The 5 latest of 6 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.

K112893Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
4 other devices also cite its predicate K112893.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 the administration of fluids from a container into the patient's vascular system through a vascular access device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180739 · printed Nov 4, 2026

Cite this page

510(k) Report. “K180739: Clearlink System Solution Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180739

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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