510(k) · Cleared
ClearedSegmented Esophageal Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · ESW Prosthesis, Esophageal
Cleared on May 29, 2019 as substantially equivalent to K072094 (M.I.Tech Co., Ltd., 2008) after a 224-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- May 29, 2019
- Review
- 224 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925406 (1995). 6 ancestors in all, the oldest K940838 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
- 3 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
- 2 generations backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- 1 generation backK072094 ChoostentM.I.Tech Co., Ltd. · 2008
- This deviceK182910 Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925406 | Biliary Endoprostheses W/Unistep Delivery System | Schneider Intl., Ltd. | 1995 | — |
| −3 | K962899 | Ultraflex Diamond | Boston Scientific Corp | 1997 | — |
| −2 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| −1 | K072094 | Choostent | M.I.Tech Co., Ltd. | 2008 | — |
| 0 (this device) | K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 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 ESW? 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 ESW device
- #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 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 |
|---|---|---|---|
| * | K072094 | ChoostentSummary page 4…n: 2 Product Code: ESW Regulation Number: 878.3610 Review Panel: Gastroenterology/Urology 4. Identification of Predicate Device 510(k) Number: K072094 Product Name: CHOOSTENTTM Covered Esophageal Stent Page 1 of 6… | 2008 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K072094.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ESW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ESW
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ESW
25in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESW
120in 2025
MAUDE reports naming product code ESW, 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 | 88 |
| 2008 | 5 | 99 | 0 | 153 |
| 2009 | 3 | 35 | 0 | 239 |
| 2010 | 3 | 206 | 25 | 255 |
| 2011 | 1 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 121 |
| 2013 | 2 | — | 0 | 145 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 175 |
| 2016 | 1 | — | 0 | 153 |
| 2017 | 0 | — | 0 | 87 |
| 2018 | 2 | — | 0 | 86 |
| 2019 | 1 | — | 0 | 167 |
| 2020 | 1 | — | 0 | 155 |
| 2021 | 4 | 139 | 0 | 77 |
| 2022 | 1 | — | 0 | 109 |
| 2023 | 0 | — | 0 | 155 |
| 2024 | 4 | 130 | 0 | 166 |
| 2025 | 3 | 90 | 0 | 120 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182910: Segmented Esophageal Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182910
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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