510(k) · Cleared

Cleared

Maxcess Needlefree - Y- Site (100713)

K970800510(k) TraditionalCleared Apr 2, 199729-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 Apr 2, 1997 as substantially equivalent to K960661 (Solopak Medical Products, Inc., 1996) after a 29-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.

Decided: Apr 2, 1997
Review: 29 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K915571 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
1 generation backK960661 Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc. · 1996
This deviceK970800 Maxcess Needlefree - Y- Site (100713)Solopak Medical Products, Inc. · 1997
Descendant · cites it directly · 0 of its ownK981547 NFC Needlefree Y-Site, Model 69970Filtertek, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all

K981547NFC Needlefree Y-Site, Model 69970Filtertek, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K970800, 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.

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

Get a 510(k) Report

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
*	K960661	Maxcess Needle Free Connector (8200) Summary page 1 …named in this submission. The named predicate device in this submission is the Maxcess™ NeedleFree Connector currently marketed by Douglas Medical Products under 510(k) #K960661. The Douglas Medical Products Maxcess™ NeedleFree Y-Site is _ sterilized per AAMI guidelines to a 10 sterility assurance level. E…	Solopak Medical Products, Inc.	1996	—

Also cleared against K960661: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K981547	NFC Needlefree Y-Site, Model 69970	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?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K981547 (Filtertek, Inc., 1998) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K960661.

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 Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient’s vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site 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/K970800 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970800: Maxcess Needlefree - Y- Site (100713).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970800

Report an extraction error

Are you the manufacturer?

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