510(k) · Cleared
ClearedMandrel Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Medical · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Apr 8, 2014 as substantially equivalent to K011084 (Lake Region Mfg., Inc., 2001) and 1 other predicate after a 41-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Apr 8, 2014
- Review
- 41 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970994 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970994 Core and Coil Assembly GuidewireLake Region Mfg., Inc. · 1997
- 1 generation backK080508 Mandrel Guidewires or M-WireLake Region Medical · 2008
- This deviceK140482 Mandrel GuidewireLake Region Medical · 2014
- Descendant · cites it directly · 0 of its ownK142397 Predicate III GuidewireLake Region Medical · 2014
Most influential descendants
Showing 1 of 1 · See all- K142397Predicate III GuidewireLake Region Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970994 | Core and Coil Assembly Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −1 | K080508 | Mandrel Guidewires or M-Wire | Lake Region Medical | 2008 | — |
| 0 (this device) | K140482 | Mandrel Guidewire | Lake Region Medical | 2014 | — |
| +1 | K142397 | Predicate III Guidewire | Lake Region Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K011084 | Mandrel Guidewire AssemblySummary page 1…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) K080508 Mandrel Guidewires (Lake Region Medical) 2.6 DEVICE D… | 2001 |
| * | K080508 | Mandrel Guidewires or M-WireSummary page 1…art 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) K080508 Mandrel Guidewires (Lake Region Medical) 2.6 DEVICE DESCRIPTION The Mandrel wire family is made of a coated (PTFE… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142397 | Predicate III Guidewire | 2014 | 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K142397 (Lake Region Medical, 2014) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K011084.
How does its category compare?
All OCY devicesOCY 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
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?
Mandrel guidewires are intended 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/K140482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140482: Mandrel Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140482
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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