510(k) · Cleared
ClearedDisposable Distal Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirco-Tech (Nanjing) Co., Ltd. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Mar 19, 2026 as substantially equivalent to K243388 (Micro-Tech (Nanjing) Co., Ltd., 2025) after a 175-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Mar 19, 2026
- Review
- 175 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853585 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 1 generation backK243388 Disposable Distal CapMicro-Tech (Nanjing) Co., Ltd. · 2025
- This deviceK253139 Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −1 | K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025 | — |
| 0 (this device) | K253139 | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 FBN? 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 FBN device
- #1 K254153 Single-use Video Scope; PB Digital Controllerscore 14.4 · 12 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 |
|---|---|---|---|
| * | K243388 | Disposable Distal CapSummary page 5…876.1500 Product Code(s) FBN I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K243388 Disposable Distal Cap FDS Device Description Summary 21 CFR 807.92(a)(4) Disposable Distal Cap is used with the cholangioscope a… | 2025 |
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 40 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All FBN devicesFBN Choledochoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FBN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBN
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBN
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FBN
118in 2025
MAUDE reports naming product code FBN, 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 | 1 |
| 2008 | 3 | 64 | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 168 |
| 2017 | 0 | — | 0 | 224 |
| 2018 | 1 | — | 0 | 639 |
| 2019 | 1 | — | 0 | 105 |
| 2020 | 1 | — | 1 | 173 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 0 | — | 0 | 283 |
| 2023 | 4 | 215 | 1 | 105 |
| 2024 | 2 | — | 1 (1) | 107 |
| 2025 | 3 | 150 | 0 | 118 |
| 2026 | 3 | 175 | 1 | — |
What is it indicated for?
Disposable Distal Cap is used with the cholangioscope and installed to the distal end of cholangioscope to
keep appropriate endoscopic field of view.
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/K253139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253139: Disposable Distal Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253139
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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