510(k) · Cleared
Recalled · 2010Habib 4X
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 Aug 15, 2005 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 15, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK051420 Habib 4XEmcision, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK071103 Habib HexablateEmcision, Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK062935 Habib 4X LaparoscopicRita Medical Systems · 2006
- Descendant · 2 generations on · 0 of its ownK080717 Habib Hexablate 10Emcision, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK073687 Habib Laparoscopic HexablateEmcision, Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K071103Habib HexablateEmcision, Ltd. · 2007 · cites it directly2descendants
- K062935Habib 4X LaparoscopicRita Medical Systems · 2006 · cites it directly1descendant
- K080717Habib Hexablate 10Emcision, Ltd. · 2008 · 2 generations on0descendants
- K073687Habib Laparoscopic HexablateEmcision, Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051420 | Habib 4X | Emcision, Ltd. | 2005 | — |
| +1 | K071103 | Habib Hexablate | Emcision, Ltd. | 2007 | — |
| +1 | K062935 | Habib 4X Laparoscopic | Rita Medical Systems | 2006 | — |
| +2 | K080717 | Habib Hexablate 10 | Emcision, Ltd. | 2008 | — |
| +2 | K073687 | Habib Laparoscopic Hexablate | Emcision, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2010 | Not classified | Z-3074-2011 | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded |
| Aug 30, 2010 | Not classified | Z-3073-2011 | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded |
| Sep 21, 2005 | Not classified | Z-0031-06 | Other | Devices for which sterility may be compromised as evidenced by a loss of package integrity. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071103 (Emcision, Ltd., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 4X is intended to be used to assist in coagulation of tissue during
intraoperative surgical procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051420: Habib 4X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051420
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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