510(k) · Cleared
ClearedHabib EndoHPB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emcision, Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Mar 20, 2018 as substantially equivalent to K083292 (Emcision, Ltd., 2009) after a 57-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Mar 20, 2018
- Review
- 57 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970278 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970278 Microvasive Gold ProbeBoston Scientific Corp · 1997
- 2 generations backK072383 Habib EndoblateEmcision, Ltd. · 2007
- 1 generation backK083292 Habib EndohpbEmcision, Ltd. · 2009 · Recalled
- This deviceK180165 Habib EndoHPBEmcision, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK181758 ELRA ElectrodeStarmed Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK233113 ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S…Starmed Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK231533 Habib EndoHPBBoston Scientific Corporation · 2023
Most influential descendants
Showing 3 of 3 · See all- K181758ELRA ElectrodeStarmed Co., Ltd. · 2019 · cites it directly1descendant
- K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)Starmed Co., Ltd. · 2023 · 2 generations on0descendants
- K231533Habib EndoHPBBoston Scientific Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970278 | Microvasive Gold Probe | Boston Scientific Corp | 1997 | — |
| −2 | K072383 | Habib Endoblate | Emcision, Ltd. | 2007 | — |
| −1 | K083292 | Habib Endohpb | Emcision, Ltd. | 2009 | 1 |
| 0 (this device) | K180165 | Habib EndoHPB | Emcision, Ltd. | 2018 | — |
| +1 | K181758 | ELRA Electrode | Starmed Co., Ltd. | 2019 | — |
| +2 | K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S… | Starmed Co., Ltd. | 2023 | — |
| +1 | K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 2 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K083292 | Habib EndohpbSummary page 4…KNS 6. Identification of the Predicate Predicate Device Name Habib EndoHPB 510(k) Number K083292 7. Purpose of this Submission The main purpose of this submission is to gain clearance to expand the indication for use of… | 2009 |
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 21 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181758 (Starmed Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.
The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180165: Habib EndoHPB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180165
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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