Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermo Dma, 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) |
|---|---|---|---|---|---|
| K022108 | THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 | Thermo Dma, Inc. | 2002-07-25 | 27 | 0 |
| K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | 2001-10-16 | 49 | 0 |
| K012518 | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODE | Thermo Dma, Inc. | 2001-10-09 | 64 | 0 |
| K012525 | THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 | Thermo Dma, Inc. | 2001-10-04 | 59 | 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