Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Repackers Co. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
174 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890575 | ACCUTHERM PTS-200 | Medical Repackers Co. | 1989-05-05 | 88 | 0 |
| K882977 | ASK-300 | Medical Repackers Co. | 1989-01-05 | 174 | 0 |
| K881313 | IQK-200 | Medical Repackers Co. | 1988-05-19 | 52 | 0 |
| K881429 | YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH. | Medical Repackers Co. | 1988-04-25 | 27 | 0 |
| K874674 | AIK-100 ANESTHESIA INDUCTION KIT/TRAY | Medical Repackers Co. | 1988-03-02 | 110 | 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