510(k) · Cleared
ClearedRapid Exchange Biopsy Cap and Locking Device #4526 & 4527
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · ODC Endoscope Channel Accessory
Cleared on Mar 27, 2001 as substantially equivalent to K970052 (Boston Scientific Corp, 1997) and 2 other predicates after a 26-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Mar 27, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K970054 (1997). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970054 TandemrxBoston Scientific Corp · 1997
- This deviceK010610 Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001
- Descendant · cites it directly · 4 of its ownK040137 Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK213483 SnapLoc Wire LockWilson Cook Medical · 2022
- Descendant · 2 generations on · 0 of its ownK220247 Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210353 AutoCap RXBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK202237 Locking deviceHangzhou AGS MedTech Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040137Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004 · cites it directly4descendants
- K213483SnapLoc Wire LockWilson Cook Medical · 2022 · 2 generations on0descendants
- K220247Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022 · 2 generations on0descendants
- K210353AutoCap RXBoston Scientific Corporation · 2021 · cites it directly0descendants
- K202237Locking deviceHangzhou AGS MedTech Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970054 | Tandemrx | Boston Scientific Corp | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | K213483 | SnapLoc Wire Lock | Wilson Cook Medical | 2022 | — |
| +2 | K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +1 | K210353 | AutoCap RX | Boston Scientific Corporation | 2021 | — |
| +2 | K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K970052 | ExtractorrxSummary page 5…nd Biopsy Cap System is substantially equivalent to other devices in the Microvasive® Rapid Exchange™ device family, including the following: Microvasive® Extractor Rx (K970052) Microvasive® Ultratome Rx (K970053) Microvasive® Tandem Rx (K970054) This submission is a Special 510(k): Device Modification… | 1997 |
| * | K970053 | UltratomerxSummary page 5…equivalent to other devices in the Microvasive® Rapid Exchange™ device family, including the following: Microvasive® Extractor Rx (K970052) Microvasive® Ultratome Rx (K970053) Microvasive® Tandem Rx (K970054) This submission is a Special 510(k): Device Modification as described in FDA’s guidance docum… | 1997 |
| * | K970054 | TandemrxSummary page 5…e Microvasive® Rapid Exchange™ device family, including the following: Microvasive® Extractor Rx (K970052) Microvasive® Ultratome Rx (K970053) Microvasive® Tandem Rx (K970054) This submission is a Special 510(k): Device Modification as described in FDA’s guidance document entitled “The New 510(k) Parad… | 1997 |
What descends from it? (6)
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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K040137 (Wilson-Cook Medical, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of two accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices:
The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures.
The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.
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/K010610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010610: Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010610
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026