Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Schwartz Electro-Optics, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
188 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980710 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE | Schwartz Electro-Optics, Inc. | 1998-05-22 | 87 | 0 |
| K980313 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | Schwartz Electro-Optics, Inc. | 1998-03-19 | 51 | 0 |
| K973867 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM | Schwartz Electro-Optics, Inc. | 1998-02-10 | 141 | 0 |
| K974039 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | Schwartz Electro-Optics, Inc. | 1998-01-12 | 88 | 0 |
| K973603 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYST | Schwartz Electro-Optics, Inc. | 1997-12-19 | 88 | 0 |
| K971404 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FO | Schwartz Electro-Optics, Inc. | 1997-07-09 | 84 | 0 |
| K953585 | SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER | Schwartz Electro-Optics, Inc. | 1996-02-05 | 188 | 0 |
| K954013 | TRILASE 2940 ERBIUM LASER | Schwartz Electro-Optics, Inc. | 1996-01-31 | 159 | 0 |
| K952554 | SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM | Schwartz Electro-Optics, Inc. | 1995-08-28 | 87 | 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