510(k) · Cleared
ClearedOmnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trimedyne, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 12, 1999 after a 10-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 10 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK992230 Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model…Trimedyne, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK022655 Trimedyne Side Firing Needle with Vent SheathTrimedyne, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK050412 VapormaxTrimedyne, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK053457 Vapormax IITrimedyne, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK233157 VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K022655Trimedyne Side Firing Needle with Vent SheathTrimedyne, Inc. · 2002 · cites it directly3descendants
- K050412VapormaxTrimedyne, Inc. · 2005 · cites it directly2descendants
- K053457Vapormax IITrimedyne, Inc. · 2005 · 2 generations on1descendant
- K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992230 | Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP | Trimedyne, Inc. | 1999 | — |
| +1 | K022655 | Trimedyne Side Firing Needle with Vent Sheath | Trimedyne, Inc. | 2002 | — |
| +1 | K050412 | Vapormax | Trimedyne, Inc. | 2005 | — |
| +2 | K053457 | Vapormax II | Trimedyne, Inc. | 2005 | — |
| +3 | K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | Trimedyne OmniTip™ Switchable Tips Named without a submission number | |
| * | — | Tapertip™ Holmium Arthroscopic Handpieces Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K022655 (Trimedyne, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium:YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.
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/K992230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992230: Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992230
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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