Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dms Products, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
254 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891004 | RAPIDEC STAPH | Dms Products, Inc. | 1989-11-09 | 254 | 0 |
| K894805 | RAPIDEC UR | Dms Products, Inc. | 1989-09-26 | 60 | 0 |
| K890626 | RAPIDEC COLI | Dms Products, Inc. | 1989-06-02 | 115 | 0 |
| K890625 | JAMES REAGENT | Dms Products, Inc. | 1989-02-17 | 10 | 0 |
| K854733 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) | Dms Products, Inc. | 1986-03-06 | 101 | 0 |
| K854732 | API 50 CHB (CULTURE MEDIA) | Dms Products, Inc. | 1986-03-04 | 99 | 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