510(k) · Cleared
ClearedDisposable Distal Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Jun 27, 2025 as substantially equivalent to K984358 (Olympus America, Inc., 1999) after a 239-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.
- Decided
- Jun 27, 2025
- Review
- 239 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K853585 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- This deviceK243388 Disposable Distal CapMicro-Tech (Nanjing) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253139 Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| 0 (this device) | K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 FDS? 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 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 |
|---|---|---|---|
| * | K984358 | Olympus Distal Attachment, Models…Summary page 5…ble/Rigid Classification: 2 Product Code: FDS Regulation Number: 876.1500 Review Panel: Gastroenterology/Urology 4. Identification of Predicate Device 510(k) Number: K984358 Product Name: Disposable Distal Attachment Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP. 5. Indications for Use Disposable Dist… | 1999 |
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 |
|---|---|---|---|
| K253139 | Disposable Distal Cap | 2026 | 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 39 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K253139 (Mirco-Tech (Nanjing) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K984358.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243388: 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/K243388
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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