510(k) · Cleared
Recalled · Class II · 2023Habib 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 Jun 10, 2009 as substantially equivalent to K072383 (Emcision, Ltd., 2007) after a 212-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 10, 2009
- Review
- 212 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970278 (1997). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970278 Microvasive Gold ProbeBoston Scientific Corp · 1997
- 1 generation backK072383 Habib EndoblateEmcision, Ltd. · 2007
- This deviceK083292 Habib EndohpbEmcision, Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK180165 Habib EndoHPBEmcision, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK181758 ELRA ElectrodeStarmed Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK233113 ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S…Starmed Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK231533 Habib EndoHPBBoston Scientific Corporation · 2023
Most influential descendants
Showing 4 of 4 · See all- K180165Habib EndoHPBEmcision, Ltd. · 2018 · cites it directly3descendants
- K181758ELRA ElectrodeStarmed Co., Ltd. · 2019 · 2 generations on1descendant
- K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)Starmed Co., Ltd. · 2023 · 3 generations on0descendants
- K231533Habib EndoHPBBoston Scientific Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970278 | Microvasive Gold Probe | Boston Scientific Corp | 1997 | — |
| −1 | K072383 | Habib Endoblate | Emcision, Ltd. | 2007 | — |
| 0 (this device) | K083292 | Habib Endohpb | Emcision, Ltd. | 2009 | — |
| +1 | K180165 | Habib EndoHPB | Emcision, Ltd. | 2018 | — |
| +2 | K181758 | ELRA Electrode | Starmed Co., Ltd. | 2019 | — |
| +3 | K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S… | Starmed Co., Ltd. | 2023 | — |
| +2 | K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K072383 | Habib EndoblateSummary page 1…Gastroenterology-Urology (GU) KNS Predicate Device: Habib Endoblate catheter manufactured by EMcision Ltd (K072383.) Intended Use: The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist t… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180165 | Habib EndoHPB | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2023 | Class II | Z-1397-2023 | Under Investigation by firm | Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180165 (Emcision, Ltd., 2018) has gone furthest, with 3 descendants 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. 2009, 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 intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083292: 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/K083292
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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