510(k) · Cleared
ClearedDomain Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Domain Surgical, Inc. · HGI Electrocautery, Gynecologic (And Accessories)
Cleared on Oct 18, 2012 as substantially equivalent to K110439 (Domain Surgical, Inc., 2011) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- Oct 18, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- HGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933157 (1994). 24 ancestors in all, the oldest K780977 (1978). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 3 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 2 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 1 generation backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- This deviceK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK130606 Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK141484 Open FmsealerDomain Surgical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK142229 Laparoscopic FMsealerDomain Surgical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK140384 Fmwand Handpiece SEDomain Surgical, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014 · cites it directly3descendants
- K141484Open FmsealerDomain Surgical, Inc. · 2014 · 2 generations on1descendant
- K142229Laparoscopic FMsealerDomain Surgical, Inc. · 2015 · 3 generations on0descendants
- K140384Fmwand Handpiece SEDomain Surgical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −3 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −2 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −1 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| 0 (this device) | K121881 | Domain Surgical System | Domain Surgical, Inc. | 2012 | — |
| +1 | K130606 | Fmwand Ferromagnetic Surgical System | Domain Surgical, Inc. | 2014 | — |
| +2 | K141484 | Open Fmsealer | Domain Surgical, Inc. | 2014 | 1 |
| +3 | K142229 | Laparoscopic FMsealer | Domain Surgical, Inc. | 2015 | — |
| +2 | K140384 | Fmwand Handpiece SE | Domain Surgical, Inc. | 2014 | — |
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 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 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 HGI? 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 HGI device
- #1 K202915 IRIS Thermocoagulator and Digital Colposcopescore 2.1 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K110439 | Domain Surgical SystemSummary page 1…previously cleared by FDA through 51 0(k) #KI 10439. Device Description The Domain Surgical System is identical to the device cleared by FDA In510(k) #K1 10439. An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and cont… | 2011 |
| * | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesSummary page 2…l specialties to add specificity, consistent with our intended use for the device and the indications for use for the legally marketed Peak Surgery System (K082786). Safety and Biocompatibility Summar The Domain Surgical System, as originally cleared in 51 0(k) #K1 10439, is intended… | 2008 |
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 |
|---|---|---|---|
| K130606 | Fmwand Ferromagnetic Surgical System | 2014 | 3 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 7 of the 24 ancestors have a recall of any class.
- Of its descendants, K130606 (Domain Surgical, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HGI devicesHGI Electrocautery, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HGI
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · HGI
Too few HGI 510(k)s in any year since 2007 to give a median.
Recalls per year · HGI
7in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGI
41in 2025
MAUDE reports naming product code HGI, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 1 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 30 |
| 2019 | 0 | — | 3 | 127 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 1 | — | 7 | 100 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Domain Surgical System is Indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121881: Domain Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121881
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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