510(k) · Cleared

Cleared

I.V. Administration Set

K926448510(k) TraditionalCleared May 2, 1994495-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

Gainor Medical Europe, Ltd. · FPA Set, Administration, Intravascular

Cleared on May 2, 1994 after a 495-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: May 2, 1994
Review: 495 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 0

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

This deviceK926448 I.V. Administration SetGainor Medical Europe, Ltd. · 1994
Descendant · cites it directly · 0 of its ownK972493 Nipro Disposable Solution Infusion SetNipro Medical Corp. · 1997
Descendant · cites it directly · 0 of its ownK970076 Nipro Disposable Solution Infusion SetNipro Medical Corp. · 1997

Most influential descendants

Showing 2 of 2 · See all

K972493Nipro Disposable Solution Infusion SetNipro Medical Corp. · 1997 · cites it directly0descendants
K970076Nipro Disposable Solution Infusion SetNipro Medical Corp. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K926448	I.V. Administration Set	Gainor Medical Europe, Ltd.	1994	—
+1	K972493	Nipro Disposable Solution Infusion Set	Nipro Medical Corp.	1997	—
+1	K970076	Nipro Disposable Solution Infusion Set	Nipro Medical Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K926448, 1994–1997Source: 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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Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
K972493	Nipro Disposable Solution Infusion Set	Nipro Medical Corp.	1997	0
K970076	Nipro Disposable Solution Infusion Set	Nipro Medical Corp.	1997	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K972493 (Nipro Medical Corp., 1997) has gone furthest, with 0 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/K926448 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926448: I.V. Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926448

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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