510(k) · Cleared

Cleared

Techdevice Guidewire

K053028510(k) TraditionalCleared Jan 31, 200696-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

Techdevice Corporation · OCY Endoscopic Guidewire, Gastroenterology-Urology

Cleared on Jan 31, 2006 as substantially equivalent to K943737 (Boston Scientific Corp, 1994) and 2 other predicates after a 96-day review. Its family tree reaches back 1 generation to 1994.

Decided: Jan 31, 2006
Review: 96 days
Class: Class II
Product code: OCY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K933334 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK933334 Magic Torque GuidewireBoston Scientific Corp · 1994 · Recalled
This deviceK053028 Techdevice GuidewireTechdevice Corporation · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933334	Magic Torque Guidewire	Boston Scientific Corp	1994	1
0 (this device)	K053028	Techdevice Guidewire	Techdevice Corporation	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

FIG. 1 — Lineage of K053028, 1994–2006Source: 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

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
*	K943737	Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire Summary page 1 …dewire Common Name: Guidewire Classification: GCJ, Endoscope and Accessories 21 CFR 876. 1500 Predicate Devices Guidewire K943737 Boston Scientific Corporation Natick, MA 01760…	Boston Scientific Corp	1994	—
*	K935997	Platinum Plus Guidewire Summary page 1 …ices Guidewire K943737 Boston Scientific Corporation Natick, MA 01760 Guidewire K935997 Boston Scientific Corporation Natick, MA 01760…	Boston Scientific Corp	1994	6
*	K933334	Magic Torque Guidewire Summary page 1 …Guidewire K935997 Boston Scientific Corporation Natick, MA 01760 Guidewire K933334 Boston Scientific Corporation Natick, MA 01760 ProductDescription: The Guid…	Boston Scientific Corp	1994	1

Also cleared against K943737: 1 other device →

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?

2 of the 3 ancestors have a recall of any class.
1 other device also cites its predicate K943737.

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.

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?

The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053028: Techdevice Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053028

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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