510(k) · Cleared
ClearedHANAROSTENT LowAx Colon/Rectum (NNN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.I.Tech Co., Ltd. · MQR Stent, Colonic, Metallic, Expandable
Cleared on Mar 7, 2019 as substantially equivalent to K183616 (M.I.Tech Co., Ltd., 2019) after a 37-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 7, 2019
- Review
- 37 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000281 (2000). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 4 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 3 generations backK061877 Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006
- 2 generations backK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
- 1 generation backK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
- This deviceK190141 HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −4 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −3 | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery System | Boston Scientific Corp | 2006 | — |
| −2 | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus… | M.I.Tech Co., Ltd. | 2018 | — |
| −1 | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| 0 (this device) | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| +1 | K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023 | — |
| +2 | K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 MQR? 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 MQR device
- #1 K234046 WallFlex Colonic Stent System with Anchor Lock…score 8.8 · 7 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 |
|---|---|---|---|
| * | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)Summary page 4…HANAROSTENT® LowAx™ Colon/Rectum (NNN); HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) 510(k) Number: K183616 Decision Date: 01/10/2019 M.I.Tech… | 2019 |
| † | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | 2017 |
| † | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery System | 2006 |
| † | K111149 | Hanarostent Biliary (NNN) | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | 2023 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K223067 (Taewoong Medical Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K183616.
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MQR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQR
Too few MQR 510(k)s in any year since 2007 to give a median.
Recalls per year · MQR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQR
29in 2025
MAUDE reports naming product code MQR, 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 | 30 |
| 2008 | 0 | — | 0 | 144 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 0 | — | 1 | 71 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 1 | — | 0 | 104 |
| 2013 | 0 | — | 0 | 100 |
| 2014 | 0 | — | 0 | 70 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 1 | — | 0 | 44 |
| 2019 | 2 | — | 0 | 42 |
| 2020 | 2 | — | 0 | 46 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 38 |
| 2024 | 1 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
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/K190141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190141: HANAROSTENT LowAx Colon/Rectum (NNN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190141
Report an extraction error
Are you the manufacturer?
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