Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Deschutes Medical Products, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
687 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002329 | PELVX GELLHORN VAGINAL PESSARY 603-608 | Deschutes Medical Products, Inc. | 2000-09-18 | 48 | 0 |
| K994079 | REFLEX TREATMENT SYSTEM | Deschutes Medical Products, Inc. | 2000-03-01 | 90 | 0 |
| K990593 | PELVX INCONTINENCE DISH, MODEL 301-306 | Deschutes Medical Products, Inc. | 1999-05-24 | 89 | 0 |
| K974115 | PELVX RING, PELVX RING WITH SUPPORT | Deschutes Medical Products, Inc. | 1998-04-27 | 178 | 0 |
| K974116 | PELVX INCONTINENCE RING | Deschutes Medical Products, Inc. | 1998-04-27 | 178 | 0 |
| K974117 | PELVX DONUT, PELVX CUBE | Deschutes Medical Products, Inc. | 1998-04-27 | 178 | 0 |
| K934552 | PERIPUMP | Deschutes Medical Products, Inc. | 1995-08-09 | 687 | 0 |
| K951569 | SURGACTIVATOR | Deschutes Medical Products, Inc. | 1995-06-06 | 63 | 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