Deseret Medical, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Deseret Medical, Inc.” (first 1979, latest 1991), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 8 | 8 |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| IQI | Orthosis, Limb Brace | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
| LFJ | Catheter, Subclavian | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (11)
- Cardiovascular (5)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
Most recent Deseret Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913027 | VESSEL DILATOR | DRE | 1991-11-27 | 141 |
| K904648 | SAFE SYTE I.V. CATHETER PLACEMENT UNIT | FOZ | 1990-12-14 | 64 |
| K904121 | VIALON OBTURATOR | FOZ | 1990-11-08 | 63 |
| K904122 | INSYTE-A ARTERIAL CATHETERIZATION UNIT | FOZ | 1990-10-04 | 28 |
| K900116 | DESERET OPTIMA INTRAVASCULAR CATHETER | FOZ | 1990-06-18 | 160 |
| K895735 | DESERET MULTILUMEN SUBCLAVIAN CATHETER | LYY | 1990-05-18 | 233 |
| K895734 | DESERET INTRAVASCULAR CATHETER | FOZ | 1990-04-09 | 195 |
| K894033 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | DXO | 1989-10-17 | 133 |
| K893406 | DESERET PRN ADAPTER | KGZ | 1989-06-22 | 51 |
| K882798 | MULTIFLO ADAPTER | FPA | 1988-07-18 | 12 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Deseret Medical, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Deseret Pharmaceutical Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Deseret Medical, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Deseret Medical, Inc.” (first 1979, latest 1991), across 11 product codes in 5 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 Deseret Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deseret Medical, Inc. is 64 days.
Which FDA product codes appear under Deseret Medical, Inc.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 8); DXO (Transducer, Pressure, Catheter Tip, 2); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 20 Deseret Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Deseret Medical, 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.