The Montana Deaconess Medical Center: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “The Montana Deaconess Medical Center” (first 1984, latest 1984), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 5 | 5 |
| JSJ | Culture Media, Selective And Non-Differential | 2 | 2 |
| KZI | Culture Media, Enriched | 2 | 2 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (11)
Most recent The Montana Deaconess Medical Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841753 | MACCONKEY AGAR | JSI | 1984-06-07 | 41 |
| K841752 | XYLOSE-LYSINE DESOXYCHOLATE AGAR | JSI | 1984-06-07 | 41 |
| K841747 | MANNITOL SALT AGAR | JSI | 1984-06-07 | 41 |
| K841751 | LEVINE EOSIN METHYLENE BLUE AGAR | JSI | 1984-05-31 | 34 |
| K841750 | MARTIN-LEWIS AGAR | JTY | 1984-05-31 | 34 |
| K841749 | CHOCOLATE AGAR | KZI | 1984-05-31 | 34 |
| K841748 | SHEEP BLOOD AGAR | KZI | 1984-05-31 | 34 |
| K841746 | SALMONELLA-SHIGELLA AGAR | JSJ | 1984-05-31 | 34 |
| K841755 | MUELLER-HINTON AGAR | JTZ | 1984-05-14 | 17 |
| K841745 | HEKTOEN ENTERIC AGAR | JSI | 1984-05-11 | 14 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Montana Deaconess Medical Center.
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 The Montana Deaconess Medical Center?
FDA lists 11 510(k) clearances under the applicant name “The Montana Deaconess Medical Center” (first 1984, latest 1984), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Montana Deaconess Medical Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Montana Deaconess Medical Center is 34 days.
Which FDA product codes appear under The Montana Deaconess Medical Center?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 5); JSJ (Culture Media, Selective And Non-Differential, 2); KZI (Culture Media, Enriched, 2).
Next steps
- See all 11 The Montana Deaconess Medical Center clearances with predicates and recalls
- Run predicate analysis for product code JSI, The Montana Deaconess Medical Center'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.