510(k) · Cleared
Recalled · Class II · 2016Open Fmsealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Domain Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 30, 2014 as substantially equivalent to K130606 (Domain Surgical, Inc., 2014) and 1 other predicate after a 55-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 30, 2014
- Review
- 55 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933157 (1994). 33 ancestors in all, the oldest K780977 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 5 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 4 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 3 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 2 generations backK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
- 1 generation backK130606 Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
- This deviceK141484 Open FmsealerDomain Surgical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK142229 Laparoscopic FMsealerDomain Surgical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142229Laparoscopic FMsealerDomain Surgical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −5 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −4 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −3 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −2 | K121881 | Domain Surgical System | Domain Surgical, Inc. | 2012 | — |
| −1 | K130606 | Fmwand Ferromagnetic Surgical System | Domain Surgical, Inc. | 2014 | — |
| 0 (this device) | K141484 | Open Fmsealer | Domain Surgical, Inc. | 2014 | — |
| +1 | K142229 | Laparoscopic FMsealer | Domain Surgical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K130606 | Fmwand Ferromagnetic Surgical SystemSummary page 1…n Name: Electrosurgical cutting and coagulation device and accessories Name of Predicate Devices * FMwand Ferromagnetic Surgical System (Product Code GEl) #K1 30606 .LigaSure Vessel Sealing System (Product Code GEl) 51 0(k) #K043273 Device Description An electrosurgical cutting an… | 2014 |
| * | K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsSummary page 1…ies Name of Predicate Devices * FMwand Ferromagnetic Surgical System (Product Code GEl) #K1 30606 .LigaSure Vessel Sealing System (Product Code GEl) 51 0(k) #K043273 Device Description An electrosurgical cutting and coagulation device (and accessories) is a device intended to remo… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142229 | Laparoscopic FMsealer | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2016 | Class II | Z-0690-2017 | Other | Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 8 of the 33 ancestors have a recall of any class.
- Of its descendants, K142229 (Domain Surgical, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130606.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Open FMsealer is intended for use in general and gynecological surgery and other open surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of heat (coagulation) to vessels interposed between the jaws of the device. The Open FMsealer can be used to seal and ligate vessels up to 7mm and tissue bundles as large as will fit in the jaws of the Instrument.
The Open FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.
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/K141484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141484: Open Fmsealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141484
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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