510(k) · Cleared
ClearedDisposable Guidewire, Models G-205-3545S & G-205-3545A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Jul 5, 2002 as substantially equivalent to K933110 (Olympus Corp., 1993) and 2 other predicates after an 81-day review. Its family tree reaches back 2 generations to 1991. 10 later devices descend from it.
- Decided
- Jul 5, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K910722 (1991). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910722 450CM Guide Wire for G.I. UseTerumo Corp. · 1991
- 1 generation backK971937 Climber - Partially Coated Guide Wire for Endoscopic UseTerumo Medical Corp. · 1997
- This deviceK021179 Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002
- Descendant · cites it directly · 8 of its ownK091417 Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…Terumo Corp. · 2009
- Descendant · 2 generations on · 7 of its ownK122505 Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013
- Descendant · 3 generations on · 4 of its ownK141991 Single Use Preloaded Sphincterotome V (Distal Wireguided); Single…Olympus Medical Systems Copr. · 2015 · Recalled
- Descendant · 4 generations on · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK150142 Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K091417Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A…Terumo Corp. · 2009 · cites it directly8descendants
- K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013 · 2 generations on7descendants
- K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr. · 2015 · 3 generations on4descendants
- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · 4 generations on1descendant
- K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910722 | 450CM Guide Wire for G.I. Use | Terumo Corp. | 1991 | — |
| −1 | K971937 | Climber - Partially Coated Guide Wire for Endoscopic Use | Terumo Medical Corp. | 1997 | — |
| 0 (this device) | K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002 | — |
| +1 | K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A… | Terumo Corp. | 2009 | — |
| +2 | K122505 | Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 2013 | — |
| +3 | K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP | Olympus Medical Systems Copr. | 2015 | 3 |
| +4 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020 | — |
| +3 | K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | 2015 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (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 | Decided |
|---|---|---|---|
| * | K933110 | Olympus Guide WireSummary page 4…-205-3546S, G205-3545A Common Name: Guidewire Classification: Endoscope and accessories 21 CFR 876.1500 Predicate Device: Guide Wire G35-2LB (Olympus Optical Co.,Ltd.) #K933110 Climber (Terumo) . #K971937 Lagwire 5658-1/5659-1 (Boston Scientific) #K922302 D. Description of the Device(s) G-201-35-45, G-2… | 1993 |
| * | K971937 | Climber - Partially Coated Guide Wire for Endoscopic UseSummary page 4…n Name: Guidewire Classification: Endoscope and accessories 21 CFR 876.1500 Predicate Device: Guide Wire G35-2LB (Olympus Optical Co.,Ltd.) #K933110 Climber (Terumo) . #K971937 Lagwire 5658-1/5659-1 (Boston Scientific) #K922302 D. Description of the Device(s) G-201-35-45, G-202-35-45 are resin-treated c… | 1997 |
| * | K922302 | Jagwire (TM) Recanalization GuidewireSummary page 4…essories 21 CFR 876.1500 Predicate Device: Guide Wire G35-2LB (Olympus Optical Co.,Ltd.) #K933110 Climber (Terumo) . #K971937 Lagwire 5658-1/5659-1 (Boston Scientific) #K922302 D. Description of the Device(s) G-201-35-45, G-202-35-45 are resin-treated coated gidwire. Removal of the guidewire is not nece… | 1992 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091417 (Terumo Corp., 2009) has gone furthest, with 8 descendants of its own.
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 use with Olympus Endo-therapy Accessories. The instrument Is used as guidwire of endoscopic accessories for biliary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts
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/K021179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021179: Disposable Guidewire, Models G-205-3545S & G-205-3545A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021179
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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