Mr Instruments, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mr Instruments, Inc.” (first 2004, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 14 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 | 1 | 132 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 43 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mr Instruments, Inc. took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 7 | 7 |
Review panels
- Radiology (7)
Most recent Mr Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173290 | DuoFLEX Coil Suite | MOS | 2017-11-28 | 43 |
| K130706 | DUOFLEX COIL SUITE (1.5T) | MOS | 2013-07-25 | 132 |
| K110591 | MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL | MOS | 2011-03-29 | 27 |
| K080820 | TEM 3002G- HN DUAL TUNE HEAD COIL | MOS | 2008-04-02 | 9 |
| K072931 | MC 3003G-32R HEAD COIL | MOS | 2007-10-30 | 14 |
| K052200 | TEM 3000 HEAD COIL | MOS | 2005-08-19 | 7 |
| K040937 | TEM 3000 HEAD COIL | MOS | 2004-04-23 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Mr Instruments, 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 Mr Instruments, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mr Instruments, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Mr Instruments, Inc.” (first 2004, latest 2017), across 1 product code 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 Mr Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mr Instruments, Inc. is 14 days.
Which FDA product codes appear under Mr Instruments, Inc.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 7).
Next steps
- See all 7 Mr Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Mr 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, 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.