Trimedyne, Inc.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Trimedyne, Inc.” (first 1981, latest 2005), plus 2 PMA decisions, across 10 product codes in 6 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 48 | 48 |
| LNK | Laser For Gastro-Urology Use | 3 | 3 |
| LYK | Angioscope | 2 | 2 |
| FDA | Enteroscope And Accessories | 1 | 1 |
| FKR | Subsystem, Proportioning | 1 | 1 |
| GGX | Pipette, Sahli | 1 | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
| LPC | Device, Angioplasty, Laser, Coronary | 1 | 0 |
| LWX | Device. Laser Peripheral Angioplasty | 1 | 0 |
Review panels
- General and Plastic Surgery (48)
- Gastroenterology and Urology (5)
- Cardiovascular (4)
- Anesthesiology (1)
- Hematology (1)
- General Hospital (1)
Most recent Trimedyne, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053457 | VAPORMAX II | GEX | 2005-12-21 | 8 |
| K050412 | VAPORMAX | GEX | 2005-03-14 | 24 |
| K043012 | OMNIPULSE MINI, MODEL 2120 | GEX | 2004-11-17 | 15 |
| K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | GEX | 2004-09-08 | 82 |
| K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | GEX | 2002-11-07 | 90 |
| K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | GEX | 2002-09-23 | 294 |
| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | GEX | 2000-12-20 | 145 |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | GEX | 2000-11-02 | 154 |
| K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | GEX | 1999-10-29 | 88 |
| K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | GEX | 1999-07-12 | 10 |
48 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P870043 | PMA | SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER | 1988-06-30 |
| P860042 | PMA | TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE | 1987-02-27 |
Recalls
openFDA lists no recalls under a recalling firm named Trimedyne, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Trimedyne, Inc.?
FDA lists 58 510(k) clearances under the applicant name “Trimedyne, Inc.” (first 1981, latest 2005), plus 2 PMA decisions, across 10 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trimedyne, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trimedyne, Inc. is 108 days.
Which FDA product codes appear under Trimedyne, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 48); LNK (Laser For Gastro-Urology Use, 3); LYK (Angioscope, 2).
Next steps
- See all 58 Trimedyne, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Trimedyne, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.