510(k) · Cleared

Recalled · 2005

Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter

K964850510(k) TraditionalCleared Feb 25, 199784-day reviewClass II21 CFR 880.5440Recalls 5

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

Baxter Healthcare Corp · FPA Set, Administration, Intravascular

Cleared on Feb 25, 1997 as substantially equivalent to K960466 (Abbott Laboratories, 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled 5 times.

Decided: Feb 25, 1997
Review: 84 days
Class: Class II
Product code: FPA
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K960466 (1996). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK960466 Ivex-2 Extension Set with Y-Injection Site (Modification)Abbott Laboratories · 1996
This deviceK964850 Solution Administration Set with 0.22 Micron High Pressure Extended…Baxter Healthcare Corp · 1997
Descendant · cites it directly · 0 of its ownK153158 Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation · 2015 · Recalled
Descendant · cites it directly · 0 of its ownK994429 Venusa, LTD. Extension Set with FilterVenusa, Ltd. · 2000

Most influential descendants

Showing 2 of 2 · See all

K153158Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation · 2015 · cites it directly0descendants
K994429Venusa, LTD. Extension Set with FilterVenusa, Ltd. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960466	Ivex-2 Extension Set with Y-Injection Site (Modification)	Abbott Laboratories	1996	—
0 (this device)	K964850	Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter	Baxter Healthcare Corp	1997	—
+1	K153158	Solution Administration Sets with 0.2 Micron Filter	Baxter Healthcare Corporation	2015	2
+1	K994429	Venusa, LTD. Extension Set with Filter	Venusa, Ltd.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2015	1	0

FIG. 1 — Lineage of K964850, 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

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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
*	K960466	Ivex-2 Extension Set with Y-Injection Site (Modification) Summary page 1 …istration of intravenous solutions. The filter is manufactured by Millipore and has been recently cleared for marketing in Abbott solution administration sets covered by K960466. Baxter will purchase the 0.22 micron filter from Millipore and incorporate it into currently marketed solution administration s…	Abbott Laboratories	1996	—
*	—	Baxter Solution Sets with 0.22 Micron Filter Named without a submission number			—

Also cleared against K960466: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K153158	Solution Administration Sets with 0.2 Micron Filter	Baxter Healthcare Corporation	2015	0
K994429	Venusa, LTD. Extension Set with Filter	Venusa, Ltd.	2000	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 15, 2005	Not classified	Z-0641-06	Other	The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005	Not classified	Z-0642-06	Other	The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005	Not classified	Z-0652-06	Other	The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Jul 6, 2005	Not classified	Z-1100-05	Other	Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
Jul 16, 2003	Not classified	Z-1153-03	Other	There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K153158 (Baxter Healthcare Corporation, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K960466.

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 subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions.

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/K964850 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964850: Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964850

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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