Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dynamic Technology Corp. · 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) |
|---|---|---|---|---|---|
| K011537 | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE | Dynamic Technology Corp. | 2002-01-07 | 234 | 0 |
| K990159 | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | Dynamic Technology Corp. | 1999-04-19 | 90 | 0 |
| K982134 | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 | Dynamic Technology Corp. | 1999-04-14 | 301 | 0 |
| K973291 | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | Dynamic Technology Corp. | 1997-12-19 | 108 | 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