510(k) · Cleared

Cleared

Predicate III Guidewire

K142397510(k) SpecialCleared Sep 19, 201423-day reviewClass II21 CFR 876.1500

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

Lake Region Medical · OCY Endoscopic Guidewire, Gastroenterology-Urology

Cleared on Sep 19, 2014 as substantially equivalent to K011084 (Lake Region Mfg., Inc., 2001) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 1997.

Decided: Sep 19, 2014
Review: 23 days
Class: Class II
Product code: OCY
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K970994 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK970994 Core and Coil Assembly GuidewireLake Region Mfg., Inc. · 1997
2 generations backK080508 Mandrel Guidewires or M-WireLake Region Medical · 2008
1 generation backK140482 Mandrel GuidewireLake Region Medical · 2014
This deviceK142397 Predicate III GuidewireLake Region Medical · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K970994	Core and Coil Assembly Guidewire	Lake Region Mfg., Inc.	1997	—
−2	K080508	Mandrel Guidewires or M-Wire	Lake Region Medical	2008	—
−1	K140482	Mandrel Guidewire	Lake Region Medical	2014	—
0 (this device)	K142397	Predicate III Guidewire	Lake Region Medical	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K142397, 1997–2014Source: 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 OCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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
*	K011084	Mandrel Guidewire Assembly Summary page 4 …LASSIFICATION NAMES ENDOSCOPE AND ACCESSORIES (OCY); 21 CFR Part 876.1500 2.4 CLASS OF DEVICE These devices are Class II. 2.5 IDENTIFICATION OF PREDICATE DEVICE(s) K011084 Mandrel Guidewires (Lake Region Medical) K140482 Mandrel Guidewires (Lake Region Medical) 2.6 DEVICE DES…	Lake Region Mfg., Inc.	2001	—
*	K140482	Mandrel Guidewire Summary page 4 …Part 876.1500 2.4 CLASS OF DEVICE These devices are Class II. 2.5 IDENTIFICATION OF PREDICATE DEVICE(s) K011084 Mandrel Guidewires (Lake Region Medical) K140482 Mandrel Guidewires (Lake Region Medical) 2.6 DEVICE DESCRIPTION The guidewire is made of an uncoated Nitinol or Sta…	Lake Region Medical	2014	—

Also cleared against K011084: 10 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 17 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
None of the 4 ancestors has a recall.
10 other devices also cite its predicate K011084.

How does its category compare?

All OCY devices

OCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OCY

1in 2016

2007high 5 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCY

51in 2015

2007high 60 (2013) · low 41 (2014)2026

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

Recalls per year · OCY

8in 2019

2007high 8 (2019) · low 0 (2007)2026

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

Adverse event reports per year · OCY

133in 2025

2007high 283 (2015) · low 1 (2012)2025

MAUDE reports naming product code OCY, 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	1	—	0	3
2008	3	55	0	7
2009	1	—	0	7
2010	0	—	0	9
2011	0	—	0	3
2012	2	—	0	1
2013	4	60	0	32
2014	5	41	0	51
2015	3	51	0	283
2016	1	—	0	158
2017	0	—	0	85
2018	0	—	0	101
2019	0	—	8	103
2020	0	—	0	128
2021	0	—	0	94
2022	0	—	0	134
2023	0	—	0	115
2024	0	—	0	131
2025	0	—	0	133
2026	0	—	0	—

What is it indicated for?

To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142397 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142397: Predicate III Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142397

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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