510(k) · Cleared

Cleared

Blood Sampling Set

K103165510(k) TraditionalCleared Nov 10, 201014-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

Acacia, Inc. · FPA Set, Administration, Intravascular

Cleared on Nov 10, 2010 as substantially equivalent to K060231 (Elcam Medical Acal, 2006) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1986.

Decided: Nov 10, 2010
Review: 14 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K862691 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK862691 StopcockRam Development · 1986
2 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
1 generation backK060231 Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated…Elcam Medical Acal · 2006 · Recalled
This deviceK103165 Blood Sampling SetAcacia, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K862691	Stopcock	Ram Development	1986	—
−2	K022895	Elcam Stopcocks and Manifolds	Medical Device Consultants, Inc.	2002	14
−1	K060231	Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated…	Elcam Medical Acal	2006	20
0 (this device)	K103165	Blood Sampling Set	Acacia, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0

FIG. 1 — Lineage of K103165, 1986–2010Source: 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? (2)

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
*	K060231	Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock Summary page 1 …FPA PREDICATE DEVICES: Slcam Medical Closed Swabable Stopcock and Minimal Residual Volume Luer Activated Swabable Stopcock (K0602311) Acacia IV Extension Set (K895367) Substantially Equivalent To: The Acacia, Inc. Blood Sampling Se…	Elcam Medical Acal	2006	20
*	K895367	Intravenous Extension Set Summary page 1 …le Stopcock and Minimal Residual Volume Luer Activated Swabable Stopcock (K0602311) Acacia IV Extension Set (K895367) Substantially Equivalent To: The Acacia, Inc. Blood Sampling Set is substantially equivalent in intended use, principal of opera…	Medical Product Specialists	1989	6

Also cleared against K060231: 3 other devices →

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 24 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
3 of the 4 ancestors have a recall of any class.
3 other devices also cite its predicate K060231.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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 Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103165: Blood Sampling Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103165

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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