Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Psi Medical Products, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
804 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915459 | FLOWMATE HAND PUMP | Psi Medical Products, Inc. | 1994-02-15 | 804 | 0 |
| K931779 | EHL PULSE GENERATOR | Psi Medical Products, Inc. | 1994-02-15 | 312 | 0 |
| K920410 | EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB | Psi Medical Products, Inc. | 1994-02-14 | 745 | 0 |
| K926423 | S/2(TM) STOPCOCK | Psi Medical Products, Inc. | 1993-03-23 | 90 | 0 |
| K921415 | IRRIGATION TUBING SET | Psi Medical Products, Inc. | 1992-09-04 | 164 | 0 |
| K921253 | INSTRUMENT IRRIGATION PUMP | Psi Medical Products, Inc. | 1992-08-06 | 143 | 0 |
| K915458 | URETEROSCOPE | Psi Medical Products, Inc. | 1992-01-30 | 57 | 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