510(k) · Cleared
ClearedHabib Endoblate
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 Nov 29, 2007 as substantially equivalent to K970278 (Boston Scientific Corp, 1997) after a 97-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970278 (1997). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970278 Microvasive Gold ProbeBoston Scientific Corp · 1997
- This deviceK072383 Habib EndoblateEmcision, Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK083292 Habib EndohpbEmcision, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK180165 Habib EndoHPBEmcision, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK181758 ELRA ElectrodeStarmed Co., Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK233113 ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S…Starmed Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK231533 Habib EndoHPBBoston Scientific Corporation · 2023
Most influential descendants
Showing 5 of 5 · See all- K083292Habib EndohpbEmcision, Ltd. · 2009 · cites it directly4descendants
- K180165Habib EndoHPBEmcision, Ltd. · 2018 · 2 generations on3descendants
- K181758ELRA ElectrodeStarmed Co., Ltd. · 2019 · 3 generations on1descendant
- K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)Starmed Co., Ltd. · 2023 · 4 generations on0descendants
- K231533Habib EndoHPBBoston Scientific Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970278 | Microvasive Gold Probe | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K072383 | Habib Endoblate | Emcision, Ltd. | 2007 | — |
| +1 | K083292 | Habib Endohpb | Emcision, Ltd. | 2009 | 1 |
| +2 | K180165 | Habib EndoHPB | Emcision, Ltd. | 2018 | — |
| +3 | K181758 | ELRA Electrode | Starmed Co., Ltd. | 2019 | — |
| +4 | K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S… | Starmed Co., Ltd. | 2023 | — |
| +3 | K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K970278 | Microvasive Gold ProbeSummary page 1…Gastro-Renal (GRDB) GEl Predicate Devices: Gold Probe catheter manufactured by Boston Scientific Inc. (K970278) Intended Use: The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083292 | Habib Endohpb | 2009 | 4 |
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?
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. 2007, 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 Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to
enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072383: Habib Endoblate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072383
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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