510(k) · Cleared

Cleared

C-Series Homepump

K944692510(k) TraditionalCleared May 2, 1995221-day reviewClass II21 CFR 880.5440

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

Block Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on May 2, 1995 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.

Decided: May 2, 1995
Review: 221 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 0

49 later devices descend from it, 10 citing it directly. 2 of the 50 devices in this family, counting this one, have a Class I recall.

This deviceK944692 C-Series HomepumpBlock Medical, Inc. · 1995
Descendant · cites it directly · 47 of its ownK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
Descendant · cites it directly · 42 of its ownK982946 Painbuster Infusion KitI-Flow Corp. · 1998
Descendant · cites it directly · 33 of its ownK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
Descendant · cites it directly · 21 of its ownK991513 Homepump C-Series and Homepump C-Series One-Step KvoI-Flow Corp. · 1999 · Recalled
Descendant · cites it directly · 19 of its ownK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

1998high 7 (2002) · low 0 (2000)2026

Class I recalls in this family

K023318 I-Flow Elastomeric Pump with Bolus2 generations on · 2002
K081905 Accuflow and Accuflux Elastomeric Infusion Pump4 generations on · 2008

Most influential descendants

Showing 5 of 49 · See all

K980558Painbuster Infusion SystemI-Flow Corp. · 1998 · cites it directly47descendants
K982946Painbuster Infusion KitI-Flow Corp. · 1998 · cites it directly42descendants
K984502Nerve Block Infusion KitI-Flow Corp. · 1999 · cites it directly33descendants
K991513Homepump C-Series and Homepump C-Series One-Step KvoI-Flow Corp. · 1999 · cites it directly21descendants
K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · cites it directly19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944692	C-Series Homepump	Block Medical, Inc.	1995	—
+1	K980558	Painbuster Infusion System	I-Flow Corp.	1998	—
+1	K982946	Painbuster Infusion Kit	I-Flow Corp.	1998	—
+1	K984502	Nerve Block Infusion Kit	I-Flow Corp.	1999	—
+1	K991513	Homepump C-Series and Homepump C-Series One-Step Kvo	I-Flow Corp.	1999	1
+1	K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	6	0
2002	7	1
2003	3	0
2004	4	0
2005	7	0
2006	7	0
2007	1	0
2008	3	1
2009	2	0
2011	1	0
2016	3	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K944692, 1995–2026Source: 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.

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

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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? (49)

See all 49

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

Number	Device	Applicant	Decided	Descendants
K980558	Painbuster Infusion System	I-Flow Corp.	1998	47
K982946	Painbuster Infusion Kit	I-Flow Corp.	1998	42
K984502	Nerve Block Infusion Kit	I-Flow Corp.	1999	33
K991513	Homepump C-Series and Homepump C-Series One-Step Kvo	I-Flow Corp.	1999	21
K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	19
K984146	Paragon Infusion	I-Flow Corp.	1999	11
K984063	Paragon Basal/Bolus Administration Set	I-Flow Corp.	1999	9
K060258	Autofuser	Ace Medical Us, LLC	2006	1
K020660	Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo	I-Flow Corp.	2002	0
K990425	Sidekick Infusion Kit	I-Flow Corp.	1999	0

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

No FDA recall names this device.

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 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K980558 (I-Flow Corp., 1998) has gone furthest, with 47 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/K944692 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944692: C-Series Homepump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944692

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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