510(k) · Cleared

Recalled · Class II · 2025

Solution Administration Sets with 0.2 Micron Filter

K153158510(k) SpecialCleared Dec 28, 201556-day reviewClass II21 CFR 880.5440Recalls 2

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 Dec 28, 2015 as substantially equivalent to K964850 (Baxter Healthcare Corp, 1997) after a 56-day review. Its family tree reaches back 2 generations to 1996. It has been recalled 2 times.

Decided: Dec 28, 2015
Review: 56 days
Class: Class II
Product code: FPA
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K960466 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK960466 Ivex-2 Extension Set with Y-Injection Site (Modification)Abbott Laboratories · 1996
1 generation backK964850 Solution Administration Set with 0.22 Micron High Pressure Extended…Baxter Healthcare Corp · 1997 · Recalled
This deviceK153158 Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K960466	Ivex-2 Extension Set with Y-Injection Site (Modification)	Abbott Laboratories	1996	—
−1	K964850	Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter	Baxter Healthcare Corp	1997	5
0 (this device)	K153158	Solution Administration Sets with 0.2 Micron Filter	Baxter Healthcare Corporation	2015	—

FIG. 1 — Lineage of K153158, 1996–2015Source: 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

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
*	K964850	Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter Summary page 5 …Device Device Company Predicate 510(k) Clearance Date Solution Administration Sets with 0.22 Baxter Healthcare K964850 February 25, Micron Filter Corporation 1997 DESCRIPTION OF…	Baxter Healthcare Corp	1997	5

Also cleared against K964850: 1 other device →

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
Aug 29, 2025	Class II	Z-0196-2026	Process control	IV sets may leak.
Aug 29, 2025	Class II	Z-0195-2026	Process control	IV sets may leak.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K964850.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 retention of microorganisms and removal of air and particulate matter from infusion fluids.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K153158 · printed Nov 3, 2026

Cite this page

510(k) Report. “K153158: Solution Administration Sets with 0.2 Micron Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153158

Report an extraction error

Are you the manufacturer?

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