Deschutes Medical Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Deschutes Medical Products, Inc.” (first 1995, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 134 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HHW | Pessary, Vaginal | 5 | 5 |
| HIR | Perineometer | 2 | 2 |
| LJH | System, Irrigation, Urological | 1 | 1 |
Review panels
Most recent Deschutes Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002329 | PELVX GELLHORN VAGINAL PESSARY 603-608 | HHW | 2000-09-18 | 48 |
| K994079 | REFLEX TREATMENT SYSTEM | HIR | 2000-03-01 | 90 |
| K990593 | PELVX INCONTINENCE DISH, MODEL 301-306 | HHW | 1999-05-24 | 89 |
| K974117 | PELVX DONUT, PELVX CUBE | HHW | 1998-04-27 | 178 |
| K974116 | PELVX INCONTINENCE RING | HHW | 1998-04-27 | 178 |
| K974115 | PELVX RING, PELVX RING WITH SUPPORT | HHW | 1998-04-27 | 178 |
| K934552 | PERIPUMP | HIR | 1995-08-09 | 687 |
| K951569 | SURGACTIVATOR | LJH | 1995-06-06 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Deschutes Medical Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Deschutes Medical Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Deschutes Medical Products, Inc.” (first 1995, latest 2000), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Deschutes Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deschutes Medical Products, Inc. is 134 days.
Which FDA product codes appear under Deschutes Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are HHW (Pessary, Vaginal, 5); HIR (Perineometer, 2); LJH (System, Irrigation, Urological, 1).
Next steps
- See all 8 Deschutes Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HHW, Deschutes Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.