510(k) · Cleared

Recalled · 2003

Blood/Solution Set W/Pressure Pump

K881321510(k) TraditionalCleared Jun 16, 198879-day reviewClass II21 CFR 880.5440Recalls 8

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 Jun 16, 1988 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled 8 times.

Decided: Jun 16, 1988
Review: 79 days
Class: Class II
Product code: FPA
Recalls: 8
Predicates: 0

12 later devices descend from it, 2 citing it directly.

This deviceK881321 Blood/Solution Set W/Pressure PumpBaxter Healthcare Corp · 1988
Descendant · cites it directly · 7 of its ownK050115 Blood Hand Pump Administration SetCardinal Health, Alaris Products · 2005
Descendant · 2 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
Descendant · 3 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
Descendant · cites it directly · 3 of its ownK073339 Blood Component Recipient Set with Standard Size Filter and Infusion…Fenwal, Inc. · 2008
Descendant · 2 generations on · 2 of its ownK111702 Amicus Separator System- Use in Therapeutic Plasma Exchange and…Fenwal, Inc. · 2012 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005high 2 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all

K050115Blood Hand Pump Administration SetCardinal Health, Alaris Products · 2005 · cites it directly7descendants
K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 2 generations on6descendants
K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 3 generations on3descendants
K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…Fenwal, Inc. · 2008 · cites it directly3descendants
K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc. · 2012 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K881321	Blood/Solution Set W/Pressure Pump	Baxter Healthcare Corp	1988	—
+1	K050115	Blood Hand Pump Administration Set	Cardinal Health, Alaris Products	2005	—
+2	K140838	IV Administration Set with Hand Pump	B.Braun Medical, Inc.	2014	—
+3	K170595	IV Administration Sets	B.Braun Medical, Inc.	2017	19
+1	K073339	Blood Component Recipient Set with Standard Size Filter and Infusion Set with…	Fenwal, Inc.	2008	—
+2	K111702	Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for…	Fenwal, Inc.	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2012	1	0
2014	2	0
2016	2	0
2017	1	0
2020	2	0
2021	1	0
2022	1	0

FIG. 1 — Lineage of K881321, 1988–2022Source: 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

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
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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? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K050115	Blood Hand Pump Administration Set	Cardinal Health, Alaris Products	2005	7
K073339	Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…	Fenwal, Inc.	2008	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 16, 2003	Not classified	Z-1174-03	Other	There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
Jul 16, 2003	Not classified	Z-1165-03	Other	There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
Jul 16, 2003	Not classified	Z-1173-03	Other	There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
Dec 18, 2002	Not classified	Z-0451-03	Other	Leakage may occur at the inlet port
Dec 18, 2002	Not classified	Z-0452-03	Other	Leakage may occur at the inlet port
Dec 18, 2002	Not classified	Z-0448-03	Other	Leakage may occur at the inlet port
Dec 18, 2002	Not classified	Z-0449-03	Other	Leakage may occur at the inlet port
Dec 18, 2002	Not classified	Z-0453-03	Other	Leakage may occur at the inlet port

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

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K050115 (Cardinal Health, Alaris Products, 2005) has gone furthest, with 7 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/K881321 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881321: Blood/Solution Set W/Pressure Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881321

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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