510(k) · Cleared

Cleared

Boomerang Wire

K061075510(k) SpecialCleared Sep 1, 2006137-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiva Medical, Inc. · DXC Clamp, Vascular

Cleared on Sep 1, 2006 as substantially equivalent to K041486 (Cardiva Medical, Inc., 2004) and 2 other predicates after a 137-day review. Its family tree reaches back 1 generation to 1992. 13 later devices descend from it.

Decided: Sep 1, 2006
Review: 137 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K915280 (1992). 3 ancestors in all. 13 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK915280 FemostopRadi Medical Systems AB · 1992
This deviceK061075 Boomerang WireCardiva Medical, Inc. · 2006
Descendant · cites it directly · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
Descendant · 2 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
Descendant · 3 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
Descendant · 4 generations on · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
Descendant · 5 generations on · 8 of its ownK113110 Axera Access SystemArstasis, Inc. · 2011

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2010high 3 (2010) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all

K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · cites it directly12descendants
K100615Arstasis Access SystemArstasis, Inc. · 2010 · 2 generations on11descendants
K102728Arstasis Access SystemArstasis, Inc. · 2010 · 3 generations on10descendants
K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · 4 generations on9descendants
K113110Axera Access SystemArstasis, Inc. · 2011 · 5 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915280	Femostop	Radi Medical Systems AB	1992	—
0 (this device)	K061075	Boomerang Wire	Cardiva Medical, Inc.	2006	—
+1	K091006	Itg Vascular Access System, Model 300	Arstasis, Inc.	2010	1
+2	K100615	Arstasis Access System	Arstasis, Inc.	2010	1
+3	K102728	Arstasis Access System	Arstasis, Inc.	2010	1
+4	K103143	Arstasis One Latchwire Access System	Arstasis, Inc.	2011	—
+5	K113110	Axera Access System	Arstasis, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2011	2	0
2012	1	0
2013	3	0
2014	3	0
2015	1	0

FIG. 1 — Lineage of K061075, 1992–2015Source: 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 DXC? 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 DXC device

#1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 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	Applicant	Decided	Recalls
*	K041486	Vasostasis Vascular Closure System Summary page 1 …d Access Device and Accessories (21 C.F.R. § 870.5540) Classification: Class 11 PREDICATE DEVICES Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStop TM System (K915280) CardioThoracic Systems, Inc., CTS FloCoil T M Shunt (K970638) INTENDED US…	Cardiva Medical, Inc.	2004	—
*	K915280	Femostop Summary page 1 …Classification: Class 11 PREDICATE DEVICES Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStop TM System (K915280) CardioThoracic Systems, Inc., CTS FloCoil T M Shunt (K970638) INTENDED USE/INDICATIONS FOR USE The Cardiva Medical BoomeranQ1…	Radi Medical Systems AB	1992	—
*	K970638	CTS Midcab Fixedn Diameter Coronary Shunt Summary page 1 …Cardiva Medical VasoStasis Vascular Closure System (K041486) Radi Medical Systems AB, FemoStop TM System (K915280) CardioThoracic Systems, Inc., CTS FloCoil T M Shunt (K970638) INTENDED USE/INDICATIONS FOR USE The Cardiva Medical BoomeranQ1 m N Wire is intended to promote hemostasis at arteriotomv sit…	Cardiothoracic Systems, Inc.	1997	—

Also cleared against K041486: 2 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K091006	Itg Vascular Access System, Model 300	Arstasis, Inc.	2010	12

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?

None of the 3 ancestors has a recall.
Of its descendants, K091006 (Arstasis, Inc., 2010) has gone furthest, with 12 descendants of its own.
2 other devices also cite its predicate K041486.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXC

2in 2025

2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007high 215 (2023) · low 29 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXC

2in 2023

2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, 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	10	52	0	298
2008	3	29	2	302
2009	4	83	2	539
2010	2	—	1	600
2011	6	51	3	691
2012	5	73	0	548
2013	14	89	0	920
2014	4	157	1	494
2015	5	71	0	374
2016	3	91	0	494
2017	3	90	0	416
2018	2	—	0	391
2019	2	—	0	393
2020	3	209	0	404
2021	6	37	0	371
2022	1	—	1	273
2023	4	215	2	674
2024	1	—	0	375
2025	2	—	0	442
2026	4	125	0	—

What is it indicated for?

The Cardiva Medical BoomerangTM Wire is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The BoomerangTM Wire is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061075 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061075: Boomerang Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061075

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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