Minnesota Scientific, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Minnesota Scientific, Inc.” (first 1981, latest 1987), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| GAD | Retractor | 3 | 3 |
| GBJ | Prosthesis, Adhesive, External | 1 | 1 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 1 | 1 |
Review panels
Most recent Minnesota Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872919 | OMNI-TRACT CORRAL RETRACTOR | GAD | 1987-08-11 | 15 |
| K853948 | MINNESOTA SCIENTIFIC, INC. OMNI-BEAM | HBI | 1985-10-16 | 22 |
| K853947 | OMNI-TRACT CHEST WALL & LUNA RETRACTOR | GAD | 1985-10-16 | 22 |
| K842762 | OMNI-TRACT SURGICAL RETRACTOR SYS | GAD | 1984-08-17 | 32 |
| K810282 | OPERATING TABLE ACCESSORY CLAMP | GBJ | 1981-02-26 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Minnesota Scientific, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Minnesota Scientific, Inc. (a text match, not an official crosswalk):
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system (via GBJ)
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.
- Minnesota Laser Corp. (12 510(k)s)
- Minnesota Mining and Mfg. Co. (9 510(k)s)
- Minnesota Valley Engineering, Inc. (4 510(k)s)
- Minnesota Medical Development, Inc. (3 510(k)s)
- Minnesota Prophy Power, Inc. (2 510(k)s)
- Minnesota Medical Technologies (1 510(k)s)
- Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Minnesota Scientific, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Minnesota Scientific, Inc.” (first 1981, latest 1987), across 3 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 Minnesota Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Minnesota Scientific, Inc. is 22 days.
Which FDA product codes appear under Minnesota Scientific, Inc.?
The most frequent FDA product codes under this applicant name are GAD (Retractor, 3); GBJ (Prosthesis, Adhesive, External, 1); HBI (Illuminator, Fiberoptic, Surgical Field, 1).
Next steps
- See all 5 Minnesota Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAD, Minnesota Scientific, 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.