510(k) · Cleared

Cleared

Selectiva Guidewire

K013024510(k) TraditionalCleared Dec 4, 200188-day reviewClass II21 CFR 870.1330

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

Neometrics, Inc. · DQX Wire, Guide, Catheter

Cleared on Dec 4, 2001 as substantially equivalent to K011084 (Lake Region Mfg., Inc., 2001) after an 88-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it.

Decided: Dec 4, 2001
Review: 88 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011084 (2001). 15 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
This deviceK013024 Selectiva GuidewireNeometrics, Inc. · 2001
Descendant · cites it directly · 12 of its ownK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
Descendant · 2 generations on · 11 of its ownK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
Descendant · 2 generations on · 10 of its ownK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
Descendant · 3 generations on · 7 of its ownK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
Descendant · 4 generations on · 4 of its ownK133114 Micropuncture Introducer SetCook Incorporated · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all

K031652Vascupuncture Picc GuidewireNeometrics, Inc. · 2003 · cites it directly12descendants
K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004 · 2 generations on11descendants
K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005 · 2 generations on10descendants
K112631Vsi GuidewireVascular Solutions, Inc. · 2011 · 3 generations on7descendants
K133114Micropuncture Introducer SetCook Incorporated · 2014 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011084	Mandrel Guidewire Assembly	Lake Region Mfg., Inc.	2001	—
0 (this device)	K013024	Selectiva Guidewire	Neometrics, Inc.	2001	—
+1	K031652	Vascupuncture Picc Guidewire	Neometrics, Inc.	2003	—
+2	K040786	Vascupuncture Picc Guidewire with Hydro-Silk Coating	Neometrics, Inc.	2004	—
+2	K043398	Modification to Vascupuncture Picc Guidewire	Neometrics, Inc.	2005	—
+3	K112631	Vsi Guidewire	Vascular Solutions, Inc.	2011	—
+4	K133114	Micropuncture Introducer Set	Cook Incorporated	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	1	0
2007	1	0
2010	1	0
2011	2	0
2014	1	0
2017	1	0
2018	1	0
2023	2	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K013024, 2001–2026Source: 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 DQX? 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 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
*	K011084	Mandrel Guidewire Assembly Summary page 1 …, catheter guidewire, and wire guide Trade/Proprietary Name: Selectiva™ Guidewire Substantially Equivalent Product Lake Region Manufacturing Mandrel Guidewire Assembly (K011084). Description The Selectiva™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedu…	Lake Region Mfg., Inc.	2001	—

Also cleared against K011084: 10 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K031652	Vascupuncture Picc Guidewire	Neometrics, Inc.	2003	12
K033321	Selectiva SB Guidewire	Neometrics, Inc.	2003	1
K110739	Entellus Medical Sinus Guidewire	Entellus Medical, Inc.	2011	0
K101729	Neowire Pta/Ptca Guidewire	Neometrics, Inc.	2010	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 no recall.
Of its descendants, K031652 (Neometrics, Inc., 2003) has gone furthest, with 12 descendants of its own.
10 other devices also cite its predicate K011084.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The NeoMetrics Selectiva™ Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.

NOTE: These guidewires are not intended for PTCA 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/K013024 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013024: Selectiva Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013024

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026