510(k) · Cleared
ClearedEsg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 12, 2014 as substantially equivalent to K103032 (Olympus Winter & Ibe GmbH, 2011) after a 92-day review. Its family tree reaches back 5 generations to 1991. 11 later devices descend from it.
- Decided
- Aug 12, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911904 (1991). 13 ancestors in all. 11 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 4 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 3 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 2 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 1 generation backK103032 Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W…Olympus Winter & Ibe GmbH · 2011
- This deviceK141225 Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH · 2014
- Descendant · cites it directly · 3 of its ownK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK203682 Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved…Olympus Winter & Ibe GmbH · 2021
- Descendant · 2 generations on · 1 of its ownK212643 POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK203277 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK254056 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)…Olympus Medical Systems Corp. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · cites it directly3descendants
- K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH · 2021 · cites it directly2descendants
- K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America · 2021 · 2 generations on1descendant
- K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · cites it directly1descendant
- K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −4 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −3 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −2 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −1 | K103032 | Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch… | Olympus Winter & Ibe GmbH | 2011 | — |
| 0 (this device) | K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord | Olympus Winter & Ibe GmbH | 2014 | — |
| +1 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | 13 |
| +1 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer… | Olympus Winter & Ibe GmbH | 2021 | — |
| +2 | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Surgical Technologies America | 2021 | 7 |
| +1 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | 2021 | 4 |
| +2 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT… | Olympus Medical Systems Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K103032 | Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal…Summary page 5…y Regulations Number: 21 CFR 878.4400 Regulatory class: Class II Product code: GEI Predicate device K103032: ESG-400 Description of device The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono-… | 2011 |
| † | K081954 | Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable | 2008 |
| † | K111202 | Surgical Tissue Management System | 2012 |
| † | K944602 | Valleylab Force FX | 1995 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | 2021 | 3 |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and… | 2021 | 2 |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | 2021 | 1 |
| K182587 | Device Electrosurgical Generator ESG-150 | 2018 | 0 |
| K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | 2018 | 0 |
| K160639 | Electrosurgical Generator ESG-200 | 2016 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K211838 (Olympus Medical Systems Corporation, 2021) has gone furthest, with 3 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. 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 Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in
open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and
ancillary equipment.
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/K141225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141225
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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