Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scale-Tronix, 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) |
|---|---|---|---|---|---|
| K935609 | 4002 INFANT SCALE FOR INCUBATORS AND WARMERS | Scale-Tronix, Inc. | 1994-07-01 | 224 | 0 |
| K912662 | SCALE-TRONIX PLATFORM SCALE | Scale-Tronix, Inc. | 1992-03-27 | 283 | 0 |
| K904286 | SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED | Scale-Tronix, Inc. | 1990-10-01 | 33 | 0 |
| K902260 | SCALE-TRONIX INCUBATOR SCALE MODEL:4050 | Scale-Tronix, Inc. | 1990-08-14 | 85 | 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