510(k) · Cleared

Recalled · 2003

Homepump C-Series and Homepump C-Series One-Step Kvo

K991513510(k) TraditionalCleared Jun 21, 199952-day reviewClass II21 CFR 880.5440Recalls 1

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

I-Flow Corp. · FPA Set, Administration, Intravascular

Cleared on Jun 21, 1999 as substantially equivalent to K944692 (Block Medical, Inc., 1995) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1990. 2 of the 24 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled once.

Decided: Jun 21, 1999
Review: 52 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K896907 (1990). 2 ancestors in all. 21 later devices descend from it, 3 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK896907 3M IV Flow Regulator3M Company · 1990
This deviceK991513 Homepump C-Series and Homepump C-Series One-Step KvoI-Flow Corp. · 1999
Descendant · cites it directly · 19 of its ownK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
Descendant · 2 generations on · 17 of its ownK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
Descendant · 3 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
Descendant · 3 generations on · 8 of its ownK032642 Beeline SystemMckinley, Inc. · 2003
Descendant · 4 generations on · 7 of its ownK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002high 4 (2002) · low 0 (2007)2026

Class I recalls in this family

K023318 I-Flow Elastomeric Pump with Bolus2 generations on · 2002
K081905 Accuflow and Accuflux Elastomeric Infusion Pump6 generations on · 2008

Most influential descendants

Showing 5 of 21 · See all

K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · cites it directly19descendants
K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · 2 generations on17descendants
K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · 3 generations on15descendants
K032642Beeline SystemMckinley, Inc. · 2003 · 3 generations on8descendants
K042228Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896907	3M IV Flow Regulator	3M Company	1990	—
0 (this device)	K991513	Homepump C-Series and Homepump C-Series One-Step Kvo	I-Flow Corp.	1999	—
+1	K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	1
+2	K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	2002	—
+3	K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits	Mckinley, Inc.	2003	—
+3	K032642	Beeline System	Mckinley, Inc.	2003	—
+4	K042228	Beeline Motiv, Propolis, Pca	Mckinley, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	1
2003	2	0
2004	2	0
2005	4	0
2006	3	0
2008	1	1
2009	1	0
2016	1	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K991513, 1990–2026Source: 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? (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
*	K944692	C-Series Homepump Summary page 2 …1 This submission is intended to notify the Federal Food and Drug Administration that I-Flow Corporation is adding two new optional components to the Homepump C-Series (K944692). 1.1.1.1 Regulator (optional) 1.1.1.11 The optional reguiator controls the decreasing pressure (14 to 9 psi) of the Homepump C…	Block Medical, Inc.	1995	—
*	K896907	3M IV Flow Regulator Summary page 2 …its. Statement of Equivalence 1.2.1 The Homepump C-Series is substantially equivalent to the existing I-Flow Homepump C-Series (K944692) and the 3M \|V Flow Regulator (K896907). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTONS 2.1 2.2 2.3 Description of Device 2.1.1 212 213 214 The Homepump C-Series…	3M Company	1990	—

Also cleared against K944692: 9 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	19
K151650	SMARTez elastomeric infusion pump	Epic Medical Pte., Ltd.	2016	3
K020660	Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo	I-Flow Corp.	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 18, 2003	Not classified	Z-0741-03	Other	Overinfusion due to misassembly.

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.

K023318I-Flow Elastomeric Pump with BolusI-Flow Corp. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K020862 (I-Flow Corp., 2002) has gone furthest, with 19 descendants of its own.
9 other devices also cite its predicate K944692.

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 Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.

The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggyback infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

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/K991513 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991513: Homepump C-Series and Homepump C-Series One-Step Kvo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991513

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