510(k) · Cleared

Cleared

Multiport Manifold Set with Swabable Valves, Model 9900

K040385510(k) AbbreviatedCleared Apr 7, 200450-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

Quest Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Apr 7, 2004 as substantially equivalent to K003225 (Baxter Healthcare Corp, 2000) after a 50-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.

Decided: Apr 7, 2004
Review: 50 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003225 (2000). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
This deviceK040385 Multiport Manifold Set with Swabable Valves, Model 9900Quest Medical, Inc. · 2004
Descendant · cites it directly · 1 of its ownK151079 Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc. · 2015 · Recalled
Descendant · cites it directly · 0 of its ownK162304 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate…Quest Medical, Inc. · 2016
Descendant · cites it directly · 0 of its ownK051943 Sureflow Safety Infusion DeviceIntrasafe Medical, LLC · 2005

Most influential descendants

Showing 3 of 3 · See all

K151079Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc. · 2015 · cites it directly1descendant
K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…Quest Medical, Inc. · 2016 · cites it directly0descendants
K051943Sureflow Safety Infusion DeviceIntrasafe Medical, LLC · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003225	Solution Administration Sets with Capless Luer Activated Valve	Baxter Healthcare Corp	2000	18
0 (this device)	K040385	Multiport Manifold Set with Swabable Valves, Model 9900	Quest Medical, Inc.	2004	—
+1	K151079	Q2 Intravenous Adminstration Sets and Extension Sets	Quest Medical, Inc.	2015	1
+1	K162304	Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…	Quest Medical, Inc.	2016	—
+1	K051943	Sureflow Safety Infusion Device	Intrasafe Medical, LLC	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2015	1	0
2016	1	0

FIG. 1 — Lineage of K040385, 2000–2016Source: 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
*	K003225	Solution Administration Sets with Capless Luer Activated Valve Summary page 1 …stratiOn Sets, IV. Sets Classification: Class 1I, 21 CFR 880.5440 PREDICATE DEVICE: Baxter Continu-Flo Solution Set, 2C8930, K003225 a. DEVICE DESCRIPTION: Sterile single use, non-pyrogenic intravenous fluid…	Baxter Healthcare Corp	2000	18

Also cleared against K003225: 4 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K151079	Q2 Intravenous Adminstration Sets and Extension Sets	Quest Medical, Inc.	2015	1
K162304	Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…	Quest Medical, Inc.	2016	0
K051943	Sureflow Safety Infusion Device	Intrasafe Medical, LLC	2005	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, K151079 (Quest Medical, Inc., 2015) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K003225.

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?

For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump.

The needleless safety feature may aid in the prevention of needlestick injury.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040385: Multiport Manifold Set with Swabable Valves, Model 9900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040385

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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