510(k) · Cleared

Cleared

E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set

K970259510(k) TraditionalCleared Apr 8, 199775-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

Becton Dickinson Vascular Access, Inc. · FPA Set, Administration, Intravascular

Cleared on Apr 8, 1997 after a 75-day review. The FDA summary names its predicate without a number. 48 later devices descend from it.

Decided: Apr 8, 1997
Review: 75 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 0

48 later devices descend from it, 1 citing it directly.

This deviceK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
Descendant · cites it directly · 47 of its ownK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
Descendant · 2 generations on · 23 of its ownK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
Descendant · 3 generations on · 18 of its ownK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
Descendant · 2 generations on · 17 of its ownK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
Descendant · 3 generations on · 6 of its ownK153309 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

1998high 6 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 48 · See all

K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · cites it directly47descendants
K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · 2 generations on23descendants
K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002 · 3 generations on18descendants
K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions · 2003 · 2 generations on17descendants
K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970259	E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set	Becton Dickinson Vascular Access, Inc.	1997	—
+1	K980414	Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	1
+2	K011984	BD Vacutainer Push Button Blood Colection Set	Becton, Dickinson & CO	2001	7
+3	K022875	Modification to BD Vacutainer Push Button Blood Collection Set	Becton, Dickinson & CO	2002	—
+2	K030573	BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336…	Bd Vacutainer Systems Preanalyical Solutions	2003	5
+3	K153309	BD Vacutainer UltraTouch Push Button Blood Collection Set	Becton, Dickinson and Company	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2001	2	0
2002	1	0
2003	3	0
2005	1	0
2007	1	0
2010	4	0
2011	1	0
2013	1	0
2014	3	0
2015	1	0
2016	3	0
2017	1	0
2018	1	0
2019	2	0
2020	4	0
2022	5	0
2023	6	0
2024	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K970259, 1997–2026Source: 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.

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? (1)

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
*	—	Becton Dickinson Vascular Access E-Z SET® and SAF-T E-Z SET® brand infusion sets Named without a submission number			—

What descends from it? (48)

See all 48

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980414	Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	47

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, K980414 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 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)	—

What is it indicated for?

The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.

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/K970259 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970259: E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970259

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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