Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision Laser Products, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912853 | PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM) | Precision Laser Products, Inc. | 1991-08-20 | 53 | 0 |
| K910985 | SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA | Precision Laser Products, Inc. | 1991-07-05 | 121 | 0 |
| K910137 | PLP LAPAROSCOPIC CHOLECYSTECTOMY SET | Precision Laser Products, Inc. | 1991-04-08 | 89 | 0 |
| K910184 | PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES | Precision Laser Products, Inc. | 1991-02-21 | 37 | 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