510(k) · Cleared

Cleared

Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop Controller, Model 11216

K061115510(k) AbbreviatedCleared Jun 30, 200670-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

Gvs Spa · FPA Set, Administration, Intravascular

Cleared on Jun 30, 2006 after a 70-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jun 30, 2006
Review: 70 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK061115 Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model…Gvs Spa · 2006
Descendant · cites it directly · 0 of its ownK181870 Infusion Sets with Precision Filter for Single Use, Precision…Wuhan W.E.O Science & Technology Development Co., Ltd. · 2019
Descendant · cites it directly · 0 of its ownK080695 Mobile I.V. Systems 10,20,60Northwind Technologies, Corp. · 2008

Most influential descendants

Showing 2 of 2 · See all

K181870Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single…Wuhan W.E.O Science & Technology Development Co., Ltd. · 2019 · cites it directly0descendants
K080695Mobile I.V. Systems 10,20,60Northwind Technologies, Corp. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061115	Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215…	Gvs Spa	2006	—
+1	K181870	Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter…	Wuhan W.E.O Science & Technology Development Co., Ltd.	2019	—
+1	K080695	Mobile I.V. Systems 10,20,60	Northwind Technologies, Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2019	1	0

FIG. 1 — Lineage of K061115, 2006–2019Source: 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? (3)

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	Recalls
*	—	B. Braun; Filterflow Filtered Extension Sets Named without a submission number	—
*	—	Amsino; IN. Administration Sets Named without a submission number	—
*	—	Leventon; I.V. Extension Sets with I.V. Flow Regulators Named without a submission number	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K181870	Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single…	Wuhan W.E.O Science & Technology Development Co., Ltd.	2019	0
K080695	Mobile I.V. Systems 10,20,60	Northwind Technologies, Corp.	2008	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?

Of its descendants, K181870 (Wuhan W.E.O Science & Technology Development Co., Ltd., 2019) has gone furthest, with 0 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?

Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061115: Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop Controller, Model 11216.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061115

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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