510(k) · Cleared
ClearedHabib EUS RFA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emcision, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 24, 2015 as substantially equivalent to K123061 (Bioeconeer, Inc., 2013) and 1 other predicate after a 167-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 24, 2015
- Review
- 167 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945531 (1995). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK945531 Blade ElectrodeE & M Engineering, Inc. · 1995
- 2 generations backK994075 Geiger Disposable Electrosurgical Electrode, Model 435Geiger Medical Technologies, Inc. · 1999
- 1 generation backK123061 Ace Monopolar AttachmentBioeconeer, Inc. · 2013
- This deviceK150029 Habib EUS RFAEmcision, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK181249 EUSRA RF ElectrodeStarmed Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · cites it directly · 1 of its ownK161305 Habib EUS RFAEmcision, Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK251108 Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025
- Descendant · cites it directly · 0 of its ownK170990 Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K181249EUSRA RF ElectrodeStarmed Co., Ltd. · 2018 · cites it directly2descendants
- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · 2 generations on1descendant
- K161305Habib EUS RFAEmcision, Ltd. · 2016 · cites it directly1descendant
- K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025 · 3 generations on0descendants
- K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945531 | Blade Electrode | E & M Engineering, Inc. | 1995 | — |
| −2 | K994075 | Geiger Disposable Electrosurgical Electrode, Model 435 | Geiger Medical Technologies, Inc. | 1999 | — |
| −1 | K123061 | Ace Monopolar Attachment | Bioeconeer, Inc. | 2013 | — |
| 0 (this device) | K150029 | Habib EUS RFA | Emcision, Ltd. | 2015 | — |
| +1 | K181249 | EUSRA RF Electrode | Starmed Co., Ltd. | 2018 | — |
| +2 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +1 | K161305 | Habib EUS RFA | Emcision, Ltd. | 2016 | 2 |
| +3 | K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025 | — |
| +1 | K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator | Spiration, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K123061 | Ace Monopolar AttachmentSummary page 4…GEI, JOS 6. Identification of the Predicate Predicate Device Name: ACE Monopolar Attachment 510(k) Number: K123061 Predicate Device Name: LeVeen™Standard Needle Electrode System 510(k) Number: K1… | 2013 |
| * | K140495 | Leveen Standard Needle Electrode, Leveen Coaccess Needle ElectrodeSummary page 4…0(k) Number: K123061 Predicate Device Name: LeVeen™Standard Needle Electrode System 510(k) Number: K140495 K150029, page 2 of 4 7.… | 2014 |
What descends from it? (5)
3 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 20 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K181249 (Starmed Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K123061.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.
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/K150029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150029: Habib EUS RFA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150029
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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