510(k) · Cleared
ClearedTrimedyne Side Firing Needle with Vent Sheath
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 Nov 7, 2002 as substantially equivalent to K992230 (Trimedyne, Inc., 1999) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Nov 7, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K963969 (1997). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK963969 Indigo Portable Laser System with Temperature Feedback -Model Idl…Indigo Medical, Inc. · 1997
- 1 generation backK990851 Indigo Laseroptic Treatment SystemIndigo Medical, Inc. · 1999
- This deviceK022655 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963969 | Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power… | Indigo Medical, Inc. | 1997 | — |
| −1 | K990851 | Indigo Laseroptic Treatment System | Indigo Medical, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K992230 | Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HPSummary page 1…The predicate devices for the Side Firing Needle with Vent Sheath are: 0 Trimedyne Side Firing Switchable Tip with Suction/lrrigation cleared under K992230; 0 SLT DiffuserTMFiber cleared under K010041; and 0 indigo Diffuser-TipTMFiberoptic cleared under… | 1999 |
| * | K010041 | SLT Diffuser FiberSummary page 1…Vent Sheath are: 0 Trimedyne Side Firing Switchable Tip with Suction/lrrigation cleared under K992230; 0 SLT DiffuserTMFiber cleared under K010041; and 0 indigo Diffuser-TipTMFiberoptic cleared under K990851. IV. Device Description The Side… | 2001 |
| * | K990851 | Indigo Laseroptic Treatment SystemSummary page 1…Suction/lrrigation cleared under K992230; 0 SLT DiffuserTMFiber cleared under K010041; and 0 indigo Diffuser-TipTMFiberoptic cleared under K990851. IV. Device Description The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050412 | Vapormax | 2005 | 2 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050412 (Trimedyne, Inc., 2005) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K992230.
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?
Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022655: Trimedyne Side Firing Needle with Vent Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022655
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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