Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LKW — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
171 daysmedian FDA review time
200 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875042 | ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY | Surgilase, Inc. | 1988-06-24 | 200 | 0 |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Cooper Lasersonics, Inc. | 1988-03-11 | 56 | 0 |
| K864166 | 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY | Weck Surgical Systems | 1987-02-10 | 110 | 0 |
| K853580 | MEDILAS 2 | Endo Lase, Inc. | 1986-02-13 | 171 | 0 |
| K844440 | MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL | Cooper Lasersonics, Inc. | 1985-05-09 | 174 | 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