Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Laser, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
141 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913136 | LASER ENDOSCOPE DISC DECOMPRESSION KITS | Medical Laser, Inc. | 1991-11-01 | 108 | 0 |
| K912265 | MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 | Medical Laser, Inc. | 1991-10-10 | 141 | 0 |
| K912447 | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 | Medical Laser, Inc. | 1991-09-27 | 116 | 0 |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Medical Laser, Inc. | 1991-08-12 | 91 | 0 |
| K901464 | MEDILASE SERIES 2200 ENDOSCOPE | Medical Laser, Inc. | 1990-08-07 | 132 | 0 |
| K900894 | MEDILASE SERIES 2100 ENDOSCOPE | Medical Laser, Inc. | 1990-06-22 | 115 | 0 |
| K900380 | MEDILASE 5010 ENDOSCOPE CONSOLE | Medical Laser, Inc. | 1990-05-15 | 109 | 0 |
| K895837 | MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR | Medical Laser, Inc. | 1989-12-14 | 72 | 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