510(k) · Cleared
ClearedChoostent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.I.Tech Co., Ltd. · ESW Prosthesis, Esophageal
Cleared on Sep 25, 2008 as substantially equivalent to K012883 (Boston Scientific Corp, 2001) after a 423-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Sep 25, 2008
- Review
- 423 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925406 (1995). 5 ancestors in all, the oldest K940838 (1994). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
- 2 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
- 1 generation backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- This deviceK072094 ChoostentM.I.Tech Co., Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK092144 Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S.…Endochoice, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK140472 Bonastent Tracheal / BronchialEndochoice, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK201342 HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK182910 Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK093537 Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd. · 2010
Most influential descendants
Showing 5 of 5 · See all- K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc. · 2010 · cites it directly2descendants
- K140472Bonastent Tracheal / BronchialEndochoice, Inc. · 2014 · 2 generations on1descendant
- K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. · 2020 · 3 generations on0descendants
- K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2019 · cites it directly0descendants
- K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925406 | Biliary Endoprostheses W/Unistep Delivery System | Schneider Intl., Ltd. | 1995 | — |
| −2 | K962899 | Ultraflex Diamond | Boston Scientific Corp | 1997 | — |
| −1 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| 0 (this device) | K072094 | Choostent | M.I.Tech Co., Ltd. | 2008 | — |
| +1 | K092144 | Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange… | Endochoice, Inc. | 2010 | — |
| +2 | K140472 | Bonastent Tracheal / Bronchial | Endochoice, Inc. | 2014 | — |
| +3 | K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020 | — |
| +1 | K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019 | — |
| +1 | K093537 | Hanarostent Esophagus (CCC) | M.I.Tech Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Summary page 2…M. I. Tech Co., Ltd. Product Name Ultraflex TM CHOOSTENTTM 510(k) K012883 Indication for use The proposed Ultraflex Esophageal Stent The CHOOSTENTTM covered Sy… | 2001 |
What descends from it? (5)
3 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K092144 (Endochoice, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K012883.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CHOOSTENTTM covered esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072094: Choostent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072094
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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