Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amuchina Intl., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
343 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992016 | AMUKIN D | Amuchina Intl., Inc. | 2000-01-10 | 209 | 0 |
| K952302 | AMUCHINA | Amuchina Intl., Inc. | 1995-07-26 | 71 | 0 |
| K871583 | MODIFIED LABELING FOR AMUKIN-50% | Amuchina Intl., Inc. | 1987-07-09 | 77 | 0 |
| K862928 | AMUKIN-50% FOR CAPD Y-SET | Amuchina Intl., Inc. | 1987-03-09 | 220 | 0 |
| K852359 | AMUCHINA/DIALYZER DISINFECTANT | Amuchina Intl., Inc. | 1986-05-13 | 343 | 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