Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mui Scientific — 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) |
|---|---|---|---|---|---|
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017-03-14 | 405 | 0 |
| K122294 | PRESSURIZED INFUSION PUMP | Mui Scientific | 2012-11-01 | 93 | 0 |
| K120524 | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM | Mui Scientific | 2012-06-21 | 120 | 0 |
| K823701 | MOTILITY CATHETERS | Mui Scientific | 1983-02-15 | 69 | 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