510(k) · Cleared
ClearedCleverLock Guidewire Locking Device and Biopsy Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Surgical Technologies America · ODC Endoscope Channel Accessory
Cleared on Apr 4, 2019 as substantially equivalent to K040137 (Wilson-Cook Medical, Inc., 2004) after a 63-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Apr 4, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970054 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK970054 TandemrxBoston Scientific Corp · 1997
- 2 generations backK010610 Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001
- 1 generation backK040137 Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004
- This deviceK190164 CleverLock Guidewire Locking Device and Biopsy CapOlympus Surgical Technologies America · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970054 | Tandemrx | Boston Scientific Corp | 1997 | — |
| −2 | K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 | Boston Scientific Corp | 2001 | — |
| −1 | K040137 | Wilson-Cook Usw Cap and Wire Lock | Wilson-Cook Medical, Inc. | 2004 | — |
| 0 (this device) | K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 ODC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K040137 | Wilson-Cook Usw Cap and Wire LockSummary page 4…and Biopsy Cap Generic/Common Name: Locking device Predicate Device Wilson-Cook USW Cap and Wire Lock K040137 6… | 2004 |
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 22 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K040137.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 0 | — | 0 | 0 |
| 2008 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.
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/K190164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190164: CleverLock Guidewire Locking Device and Biopsy Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190164
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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