Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trimedyne, Inc. — Predicate Candidate Screening
58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
372 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053457 | VAPORMAX II | Trimedyne, Inc. | 2005-12-21 | 8 | 0 |
| K050412 | VAPORMAX | Trimedyne, Inc. | 2005-03-14 | 24 | 0 |
| K043012 | OMNIPULSE MINI, MODEL 2120 | Trimedyne, Inc. | 2004-11-17 | 15 | 0 |
| K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | Trimedyne, Inc. | 2004-09-08 | 82 | 0 |
| K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | Trimedyne, Inc. | 2002-11-07 | 90 | 0 |
| K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230- | Trimedyne, Inc. | 2002-09-23 | 294 | 0 |
| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HO | Trimedyne, Inc. | 2000-12-20 | 145 | 0 |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER | Trimedyne, Inc. | 2000-11-02 | 154 | 0 |
| K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOL | Trimedyne, Inc. | 1999-10-29 | 88 | 0 |
| K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, | Trimedyne, Inc. | 1999-07-12 | 10 | 0 |
| K973172 | RESPOSABLE BARE FIBERS | Trimedyne, Inc. | 1998-02-03 | 162 | 0 |
| K970422 | RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL10 | Trimedyne, Inc. | 1997-04-21 | 77 | 0 |
| K964585 | RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) | Trimedyne, Inc. | 1997-04-17 | 153 | 0 |
| K962632 | OMNIPULSE/OMNIPULSE-MAX | Trimedyne, Inc. | 1997-01-16 | 195 | 0 |
| K954597 | RIGHT ANGLE LASER FIBERS | Trimedyne, Inc. | 1996-03-11 | 160 | 0 |
| K953494 | TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS EN | Trimedyne, Inc. | 1995-09-14 | 51 | 0 |
| K951562 | OMNIPULSE-MAX HOLMIUM LASER | Trimedyne, Inc. | 1995-07-21 | 108 | 0 |
| K944204 | LATERALASE, MODIFIED | Trimedyne, Inc. | 1994-11-28 | 108 | 0 |
| K932883 | OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM | Trimedyne, Inc. | 1994-06-21 | 372 | 0 |
| K941419 | DISPOSABLE SPINAL INTRODUCER SHEATH | Trimedyne, Inc. | 1994-06-21 | 90 | 0 |
| K934865 | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM | Trimedyne, Inc. | 1994-05-12 | 212 | 0 |
| K922497 | OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM | Trimedyne, Inc. | 1994-03-01 | 643 | 0 |
| K922496 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | Trimedyne, Inc. | 1994-03-01 | 643 | 0 |
| K925124 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST | Trimedyne, Inc. | 1994-03-01 | 504 | 0 |
| K925414 | LATERALASE CATHETER | Trimedyne, Inc. | 1994-03-01 | 491 | 0 |
| K923191 | SWITCHABLE TIP SYSTEM | Trimedyne, Inc. | 1993-03-31 | 274 | 0 |
| K922213 | LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK | Trimedyne, Inc. | 1993-03-20 | 312 | 0 |
| K920934 | HALOCATH LASER CATHETERS | Trimedyne, Inc. | 1992-04-29 | 61 | 0 |
| K920632 | SIDE FIRING FIBERS | Trimedyne, Inc. | 1992-04-02 | 50 | 0 |
| K915117 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | Trimedyne, Inc. | 1992-04-02 | 141 | 0 |
| K920625 | LATERALASE | Trimedyne, Inc. | 1992-04-02 | 50 | 0 |
| K915354 | LATERALASE | Trimedyne, Inc. | 1992-02-24 | 90 | 0 |
| K915223 | METAL ENCLOSED SIDE FIRING FIBERS | Trimedyne, Inc. | 1992-01-23 | 64 | 0 |
| K914952 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | Trimedyne, Inc. | 1991-12-20 | 45 | 0 |
| K913109 | LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK | Trimedyne, Inc. | 1991-10-08 | 88 | 0 |
| K911457 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | Trimedyne, Inc. | 1991-09-05 | 155 | 0 |
| K903418 | LATERALASE TM | Trimedyne, Inc. | 1991-06-24 | 328 | 0 |
| K905708 | TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM | Trimedyne, Inc. | 1991-03-28 | 97 | 0 |
| K903838 | OPTILASE (TM) MODEL 900 ARGON | Trimedyne, Inc. | 1991-03-05 | 196 | 0 |
| K903154 | CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER | Trimedyne, Inc. | 1990-11-23 | 128 | 0 |
| K902940 | CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1990-10-03 | 92 | 0 |
| K902939 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1990-10-03 | 92 | 0 |
| K902263 | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION | Trimedyne, Inc. | 1990-07-23 | 63 | 0 |
| K895538 | ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY | Trimedyne, Inc. | 1990-04-26 | 225 | 0 |
| K897157 | OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1990-02-22 | 58 | 0 |
| K895874 | OPTILASE YAG MODEL 1000 | Trimedyne, Inc. | 1990-01-03 | 91 | 0 |
| K895774 | GYN-PROBE | Trimedyne, Inc. | 1990-01-03 | 99 | 0 |
| K894977 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1989-10-10 | 64 | 0 |
| K890279 | MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER | Trimedyne, Inc. | 1989-02-07 | 26 | 0 |
| K870505 | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL | Trimedyne, Inc. | 1987-08-07 | 184 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda