510(k) · Cleared
ClearedTRIO Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omniguide, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 2, 2019 as substantially equivalent to K081939 (Omniguide, Inc., 2008) and 4 other predicates after a 164-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- May 2, 2019
- Review
- 164 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K844002 (1984). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 1 generation backK081939 Omniguide Beampath Fiber Optic Handpiece System and Sterilization TrayOmniguide, Inc. · 2008
- This deviceK183199 TRIO HandpieceOmniguide, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −1 | K081939 | Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray | Omniguide, Inc. | 2008 | — |
| 0 (this device) | K183199 | TRIO Handpiece | Omniguide, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K081939 | Omniguide Beampath Fiber Optic Handpiece System and Sterilization TraySummary page 4…Powered Laser Surgical Instrument Name of Predicate Devices: • OmniGuide® BeamPath® Fiber Optic handpiece (Product Code: GEX, 510(k) Number: K081939) • Karl Storz Endoscopy – America, Inc., Briner Bipolar Coagulation Suction Cannula (Product code: EOB, 510(k) Number: K962… | 2008 |
| * | K962396 | Ksea Bipolar Goagulating ForcepsSummary page 4…e (Product Code: GEX, 510(k) Number: K081939) • Karl Storz Endoscopy – America, Inc., Briner Bipolar Coagulation Suction Cannula (Product code: EOB, 510(k) Number: K962396/K960009) 1 • Kirwan Surgical Products, Inc., Kirwan Bipolar Coagulation Forceps (Product code: GEI, 510(k) Number: K965241/… | 1996 |
| * | K960009 | Storz S2050 Series Bipolar ForcepsSummary page 4…ct Code: GEX, 510(k) Number: K081939) • Karl Storz Endoscopy – America, Inc., Briner Bipolar Coagulation Suction Cannula (Product code: EOB, 510(k) Number: K962396/K960009) 1 • Kirwan Surgical Products, Inc., Kirwan Bipolar Coagulation Forceps (Product code: GEI, 510(k) Number: K965241/K900533)… | 1996 |
| * | K965241 | Bipolar Suction CoagulatorSummary page 4…a (Product code: EOB, 510(k) Number: K962396/K960009) 1 • Kirwan Surgical Products, Inc., Kirwan Bipolar Coagulation Forceps (Product code: GEI, 510(k) Number: K965241/K900533) 2 Indications for Use: The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body ti… | 1997 |
| * | K900533 | Disposable Bipolar Coagulating ForcepsSummary page 4…ct code: EOB, 510(k) Number: K962396/K960009) 1 • Kirwan Surgical Products, Inc., Kirwan Bipolar Coagulation Forceps (Product code: GEI, 510(k) Number: K965241/K900533) 2 Indications for Use: The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues an… | 1990 |
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 35 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 16 ancestors has a recall.
- 1 other device also cites its predicate K081939.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® BeamPath® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Gynecology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183199: TRIO Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183199
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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