510(k) · Cleared
ClearedHANAROSTENT Esophagus Asymmetric (CCC)
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 Nov 18, 2021 as substantially equivalent to K201160 (M.I.Tech Co., Ltd., 2021) after a 49-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Nov 18, 2021
- Review
- 49 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K925406 (1995). 19 ancestors in all, the oldest K940838 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
- 6 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
- 5 generations backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- 4 generations backK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
- 3 generations backK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
- 2 generations backK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
- 1 generation backK201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021
- This deviceK213251 HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925406 | Biliary Endoprostheses W/Unistep Delivery System | Schneider Intl., Ltd. | 1995 | — |
| −6 | K962899 | Ultraflex Diamond | Boston Scientific Corp | 1997 | — |
| −5 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| −4 | K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corp | 2008 | — |
| −3 | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… | Boston Scientific Corporation | 2009 | — |
| −2 | K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| −1 | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021 | — |
| 0 (this device) | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 15.3 · 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 |
|---|---|---|---|
| * | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)Summary page 5…STENT® Esophagus (CCC) Applicant: M.I.Tech Co., Ltd. 510(k) Number: K201160 Clearance Date: July 23, 2021 Device:… | 2021 |
| † | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720… | 2009 |
| † | K955347 | Ultraflex | 1996 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K201160.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
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/K213251 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213251: HANAROSTENT Esophagus Asymmetric (CCC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213251
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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