510(k) · Cleared
ClearedNiti-S SPAXUS Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taewoong Medical Co., Ltd. · PCU Pancreatic Stent, Covered, Metallic, Removable
Cleared on Mar 13, 2026 as substantially equivalent to K233318 (Boston Scientific Corporation, 2023) and 3 other predicates after a 204-day review. Its family tree reaches back 10 generations to 1997. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 13, 2026
- Review
- 204 days
- Class
- Class II
- Product code
- PCU
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K970053 (1997). 17 ancestors in all. No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 6 generations between
- 3 generations backK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
- 2 generations backK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- 1 generation backK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
- This deviceK252648 Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 9 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 8 generations backK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
- 7 generations backK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015
- 6 generations backK152572 AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015
- 5 generations backK153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery…Boston Scientific Corporation · 2015
- 4 generations backK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- 3 generations backK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
- 2 generations backK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- 1 generation backK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
- This deviceK252648 Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026
Class I recalls in this family
- K233318 AXIOS Stent and Electrocautery-Enhanced Delivery…direct predicate · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −9 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −8 | K022595 | Wilson-Cook Cystotome | Wilson-Cook Medical, Inc. | 2002 | — |
| −7 | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015 | — |
| −6 | K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | 2015 | — |
| −5 | K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced… | Boston Scientific Corporation | 2015 | — |
| −4 | K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2017 | — |
| −3 | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced… | Boston Scientific Corporation | 2019 | 8 |
| −2 | K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019 | — |
| −1 | K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022 | — |
| 0 (this device) | K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 1 |
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.
1 device in this family has a Class I recall. 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 PCU device
- #1 K220112 AXIOS Stent and Electrocautery-Enhanced…score 9.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and…Summary page 5…MATION Primary Predicate AXIOS Stent and Electrocautery-Enhanced Delivery System Device Name: 510(k) Number: K233318 Manufacturer: Boston Scientific Reference Device Name: Esophageal TTS Stent… | 2023 |
| * | K203132 | AXIOS Stent and Electrocautery Enhanced Delivery SystemSummary page 7…Enhanced Delivery System 510(k) Number K252648 (subject device) K203132, K220112, K233318 Regulation 21 CFR 876.5015 (Pancreatic drainage stent 21 CFR 876.5015 (Pancreatic Drainage St… | 2021 |
| * | K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery SystemSummary page 7…Enhanced Delivery System 510(k) Number K252648 (subject device) K203132, K220112, K233318 Regulation 21 CFR 876.5015 (Pancreatic drainage stent 21 CFR 876.5015 (Pancreatic Drainage Stent… | 2022 |
| * | DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent…Summary page 8…y- Enhanced Delivery System 510(k) Number K252648 (subject device) DEN230019, K233318 Regulation 21 CFR 876.5016 - Gallbladder drainage 21 CFR 876.5016 - Gallbladder drainage… | 2023 |
| † | K240522 | Esophageal TTS Stent | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233318AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced…Boston Scientific Corporation · 2023 · Direct predicate · ◆ in the 2023 ancestors bar of FIG. 16 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PCU devicesPCU Pancreatic Stent, Covered, Metallic, Removable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PCU
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PCU
46in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCU
6in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCU
292in 2025
MAUDE reports naming product code PCU, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 3 | 46 | 0 | 17 |
| 2016 | 0 | — | 0 | 101 |
| 2017 | 1 | — | 0 | 95 |
| 2018 | 0 | — | 0 | 90 |
| 2019 | 2 | — | 0 | 136 |
| 2020 | 0 | — | 6 | 144 |
| 2021 | 1 | — | 0 | 162 |
| 2022 | 1 | — | 0 | 208 |
| 2023 | 0 | — | 0 | 260 |
| 2024 | 0 | — | 0 | 416 |
| 2025 | 0 | — | 0 | 292 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
8mmx20mm stents: The Niti-S SPAXUST™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution. 10mmx20mm and 16mmx20mm stents: The Niti-S SPAXUST™ Stent is indicated for use to…
Read the full statement (180 words)
8mmx20mm stents:
The Niti-S SPAXUST™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.
10mmx20mm and 16mmx20mm stents:
The Niti-S SPAXUST™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6 cm in size and walled-off necrosis > 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the Niti-S SPAXUS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. The Niti-S SPAXUS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
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/K252648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252648: Niti-S SPAXUS Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252648
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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