Michigan Instruments, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Michigan Instruments, Inc.” (first 1981, latest 2008), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | 6 | 6 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
Most recent Michigan Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073079 | THUMPER, MODEL: 1008 | DRM | 2008-02-14 | 106 |
| K972525 | THUMPER | DRM | 1997-10-02 | 87 |
| K962237 | THUMPER CARDIOPULMONARY RESUSCITATOR | DRM | 1996-09-05 | 86 |
| K895954 | LARYNGOSTAT LARYNGOSCOPE HANDLE | CCW | 1989-10-30 | 19 |
| K851139 | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 | DRM | 1985-05-15 | 55 |
| K833879 | CARDIOPULMONARY RESUSCITATOR | DRM | 1983-12-27 | 49 |
| K811909 | CARDIOPULMUNARY RESUSCITATOR | DRM | 1981-07-16 | 15 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-02-13.
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.
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Michigan Instruments, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Michigan Instruments, Inc.” (first 1981, latest 2008), across 2 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 Michigan Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Michigan Instruments, Inc. is 55 days.
Which FDA product codes appear under Michigan Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DRM (Compressor, Cardiac, External, 6); CCW (Laryngoscope, Rigid, 1).
Next steps
- See all 7 Michigan Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRM, Michigan Instruments, 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 (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.