510(k) · Cleared

Cleared

Safe Mate I.V. Extension Sets

K962801510(k) TraditionalCleared Aug 28, 199641-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

Biological & Environmental Control Laboratories · FPA Set, Administration, Intravascular

Cleared on Aug 28, 1996 as substantially equivalent to K955821 (Medical Associates Network, Inc., 1996) and 3 other predicates after a 41-day review. Its family tree reaches back 2 generations to 1986.

Decided: Aug 28, 1996
Review: 41 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K860605 (1986). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK860605 Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic FilterMigada, Ltd. · 1986
1 generation backK955821 I.V. Administration SetsMedical Associates Network, Inc. · 1996
This deviceK962801 Safe Mate I.V. Extension SetsBiological & Environmental Control Laboratories · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K860605	Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic Filter	Migada, Ltd.	1986	—
−1	K955821	I.V. Administration Sets	Medical Associates Network, Inc.	1996	—
0 (this device)	K962801	Safe Mate I.V. Extension Sets	Biological & Environmental Control Laboratories	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	2	0

FIG. 1 — Lineage of K962801, 1986–1996Source: 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? (4)

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
*	K955821	I.V. Administration Sets Summary page 1 …nnula. These \|.V. Extension Sets utilize materials and components identical to Medical Network Associates, Incorporated's \|.V. Extension Sets reviewed by FDA in 510(k) #K955821. These sets use needleless split septum 32 components identical to and found to be substantially equivalent to I…	Medical Associates Network, Inc.	1996	—
*	K945070	Versasae Plastic Cannula- 11 Gauge Summary page 2 …less split septum 32 components identical to and found to be substantially equivalent to IMED Corporations Needleless Devices submitted under 510(k) #'s K945070, K944320, and K931173. The needleless components are made of the same material by the same foreign manufacturer. Technological da…	Imed Corp.	1995	1
*	K944320	Vented/Non-Vented Gemini Administration Set Summary page 2 …t septum 32 components identical to and found to be substantially equivalent to IMED Corporations Needleless Devices submitted under 510(k) #'s K945070, K944320, and K931173. The needleless components are made of the same material by the same foreign manufacturer. Technological data and pe…	Imed Corp.	1995	7
*	K931173	Primary Admin Set W/Univ SP-Man Below/Abv Pump CH Summary page 2 …components identical to and found to be substantially equivalent to IMED Corporations Needleless Devices submitted under 510(k) #'s K945070, K944320, and K931173. The needleless components are made of the same material by the same foreign manufacturer. Technological data and performance dat…	Imed Corp.	1994	3

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
3 of the 5 ancestors have a recall of any class.

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?

These I.V. Extension Sets are intended to provide additional protection against inadvertent "needlestick” injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Extension Sets provide for the entry to an intravascular administration set system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.

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/K962801 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962801: Safe Mate I.V. Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962801

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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