510(k) · Cleared
ClearedHANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (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 Jan 10, 2019 as substantially equivalent to K180180 (M.I.Tech Co., Ltd., 2018) after a 15-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Jan 10, 2019
- Review
- 15 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000281 (2000). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 3 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 2 generations backK061877 Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006
- 1 generation backK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
- This deviceK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK190141 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 3 of 3 · See all- K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019 · cites it directly2descendants
- K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2023 · cites it directly1descendant
- K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −3 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −2 | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery System | Boston Scientific Corp | 2006 | — |
| −1 | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus… | M.I.Tech Co., Ltd. | 2018 | — |
| 0 (this device) | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)Summary page 5…LowAx™ Colon/Rectum (NNN); HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) 510(k) Number: K180180 Decision Date: 11/02/2018 Mechanism of The delivery system is supplied for either endoscop… | 2018 |
What descends from it? (3)
2 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 19 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K190141 (M.I.Tech Co., Ltd., 2019) has gone furthest, with 2 descendants of its own.
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 produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant structures.
The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183616: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183616
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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