510(k) · Cleared
ClearedSingle Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corp. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on May 22, 2009 as substantially equivalent to K021179 (Olympus Optical Co., Ltd., 2002) after a 9-day review. Its family tree reaches back 3 generations to 1991. 8 later devices descend from it.
- Decided
- May 22, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910722 (1991). 5 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK910722 450CM Guide Wire for G.I. UseTerumo Corp. · 1991
- 2 generations backK971937 Climber - Partially Coated Guide Wire for Endoscopic UseTerumo Medical Corp. · 1997
- 1 generation backK021179 Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002
- This deviceK091417 Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…Terumo Corp. · 2009
- Descendant · cites it directly · 7 of its ownK122505 Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK141991 Single Use Preloaded Sphincterotome V (Distal Wireguided); Single…Olympus Medical Systems Copr. · 2015 · Recalled
- Descendant · 3 generations on · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK150142 Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015
- Descendant · 3 generations on · 0 of its ownK250945 Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600…Olympus Medical Systems Corp. · 2025 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013 · cites it directly7descendants
- K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr. · 2015 · 2 generations on4descendants
- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · 3 generations on1descendant
- K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015 · 2 generations on1descendant
- K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…Olympus Medical Systems Corp. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910722 | 450CM Guide Wire for G.I. Use | Terumo Corp. | 1991 | — |
| −2 | K971937 | Climber - Partially Coated Guide Wire for Endoscopic Use | Terumo Medical Corp. | 1997 | — |
| −1 | K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002 | — |
| 0 (this device) | K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A… | Terumo Corp. | 2009 | — |
| +1 | K122505 | Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 2013 | — |
| +2 | K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP | Olympus Medical Systems Copr. | 2015 | 3 |
| +3 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020 | — |
| +2 | K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | 2015 | — |
| +3 | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)… | Olympus Medical Systems Corp. | 2025 | 16 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545ASummary page 5….liva!entl n intended use, design, principle of operation / technology, materials and performance to the LinearGuide, which are manufactured by Olympus and cleared under K021179. Differences between the devices do not raise any issues of safety or effectiveness. ! A statement of substantially equivalence… | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122505 | Single Use Preloaded Sphincterotome V | 2013 | 7 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122505 (Olympus Medical Systems Corp., 2013) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K021179.
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OCY
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OCY
51in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCY
8in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCY
133in 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?
This instrument has been designed to be used with Olympus Endo-therapy Accessories. The instrument is used as guidewire of endoscopic accessories for biliary duct including not only common bile but cystic, pancreatic right and left hepatic duct.
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/K091417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091417: Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091417
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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