510(k) · Cleared

Cleared

Maxcess Needle Free Connector (8200)

K960661510(k) TraditionalCleared Mar 21, 199634-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

Solopak Medical Products, Inc. · FPA Set, Administration, Intravascular

Cleared on Mar 21, 1996 as substantially equivalent to K915571 (Icu Medical, Inc., 1992) after a 34-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.

Decided: Mar 21, 1996
Review: 34 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915571 (1992). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
This deviceK960661 Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc. · 1996
Descendant · cites it directly · 1 of its ownK970800 Maxcess Needlefree - Y- Site (100713)Solopak Medical Products, Inc. · 1997
Descendant · cites it directly · 0 of its ownK982170 Fluidsense Fluid Delivery SystemFluidsense Corp. · 1998
Descendant · cites it directly · 0 of its ownK981548 NFC Needlefree Connector Model 69900Filtertek, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK981547 NFC Needlefree Y-Site, Model 69970Filtertek, Inc. · 1998

Most influential descendants

Showing 4 of 4 · See all

K970800Maxcess Needlefree - Y- Site (100713)Solopak Medical Products, Inc. · 1997 · cites it directly1descendant
K982170Fluidsense Fluid Delivery SystemFluidsense Corp. · 1998 · cites it directly0descendants
K981548NFC Needlefree Connector Model 69900Filtertek, Inc. · 1998 · cites it directly0descendants
K981547NFC Needlefree Y-Site, Model 69970Filtertek, Inc. · 1998 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915571	Clave Connector	Icu Medical, Inc.	1992	3
0 (this device)	K960661	Maxcess Needle Free Connector (8200)	Solopak Medical Products, Inc.	1996	—
+1	K970800	Maxcess Needlefree - Y- Site (100713)	Solopak Medical Products, Inc.	1997	—
+1	K982170	Fluidsense Fluid Delivery System	Fluidsense Corp.	1998	—
+1	K981548	NFC Needlefree Connector Model 69900	Filtertek, Inc.	1998	—
+2	K981547	NFC Needlefree Y-Site, Model 69970	Filtertek, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	3	0

FIG. 1 — Lineage of K960661, 1992–1998Source: 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.

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#2 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
*	K915571	Clave Connector Summary page 1 …e predicate device named in this submission. The named predicate device in this submission is the Clavern Connector currently marketed by ICU Medical, Inc. under 510(k) #K915571. The Douglas Medical Products Maxcess Needlefree Connector is sterilized per AAMI guidelines to a 10 6 sterility assurance level.…	Icu Medical, Inc.	1992	3

Also cleared against K915571: 6 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K970800	Maxcess Needlefree - Y- Site (100713)	Solopak Medical Products, Inc.	1997	1
K982170	Fluidsense Fluid Delivery System	Fluidsense Corp.	1998	0
K981548	NFC Needlefree Connector Model 69900	Filtertek, Inc.	1998	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?

Its one ancestor has a recall.
Of its descendants, K970800 (Solopak Medical Products, Inc., 1997) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K915571.

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 Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and\or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.

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/K960661 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960661: Maxcess Needle Free Connector (8200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960661

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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