Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Trading Consultants and Distributors Intl., Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
77 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994001 | POLYGLYCOLIC ACID | Trading Consultants and Distributors Intl., Inc. | 2000-02-09 | 77 | 0 |
| K993997 | POLYPROPYLENE | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 0 |
| K993998 | NYLON | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 0 |
| K993999 | SILK | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 0 |
| K994000 | POLYESTER | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 0 |
| K994002 | PLAIN/CHROMIC CATGUT | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 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