510(k) · Cleared
ClearedTHUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 1, 2026 as substantially equivalent to K211838 (Olympus Medical Systems Corporation, 2021) after a 196-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Jul 1, 2026
- Review
- 196 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K936109 (1994). 148 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 12 generations between
- 3 generations backK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- 2 generations backK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- 1 generation backK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- This deviceK254056 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)…Olympus Medical Systems Corp. · 2026
Show all 16 generations
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 15 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 14 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 13 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 12 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 11 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 10 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 9 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 7 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 6 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 5 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 4 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 3 generations backK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- 2 generations backK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- 1 generation backK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- This deviceK254056 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)…Olympus Medical Systems Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −15 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −13 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −12 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −11 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −10 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −9 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −7 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −6 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −5 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −4 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| −3 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| −2 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| −1 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | 13 |
| 0 (this device) | 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 |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 13 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K211838 | Ultrasonic Bipolar Generator USG-410 with accessoriesSummary page 5…Predicate Device Information Device Name 510(k) Submitter 510(k) Number Ultrasonic Bipolar Olympus Medical Systems K211838 Generator USG-410 with Corporation accessories… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 148 ancestors have a recall of any class.
- 2 other devices also cite its predicate K211838.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 THUNDERBEAT Type S hand instruments are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect. Seal & Cut mode: The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections…
Read the full statement (234 words)
The THUNDERBEAT Type S hand instruments are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT Type S hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
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/K254056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254056: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254056
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026