Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dbt Medical , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
66 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851681 | SAFESTRETCH INCONTINENCE SYSTEM | Dbt Medical , Ltd. | 1985-06-28 | 66 | 0 |
| K851679 | OSTOMY BAGS COLOSTOMY | Dbt Medical , Ltd. | 1985-06-27 | 65 | 0 |
| K851680 | OSTOMY BAGS ILEOSTOMY | Dbt Medical , Ltd. | 1985-06-27 | 65 | 0 |
| K851678 | OSTOMY BAGS URETHEROSTOMY | Dbt Medical , Ltd. | 1985-06-27 | 65 | 0 |
| K851682 | SAFESEAL REUSABLE URINAL SYSTEM | Dbt Medical , Ltd. | 1985-06-24 | 62 | 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