Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mr Instruments, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
132 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173290 | DuoFLEX Coil Suite | Mr Instruments, Inc. | 2017-11-28 | 43 | 0 |
| K130706 | DUOFLEX COIL SUITE (1.5T) | Mr Instruments, Inc. | 2013-07-25 | 132 | 0 |
| K110591 | MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANN | Mr Instruments, Inc. | 2011-03-29 | 27 | 0 |
| K080820 | TEM 3002G- HN DUAL TUNE HEAD COIL | Mr Instruments, Inc. | 2008-04-02 | 9 | 0 |
| K072931 | MC 3003G-32R HEAD COIL | Mr Instruments, Inc. | 2007-10-30 | 14 | 0 |
| K052200 | TEM 3000 HEAD COIL | Mr Instruments, Inc. | 2005-08-19 | 7 | 0 |
| K040937 | TEM 3000 HEAD COIL | Mr Instruments, Inc. | 2004-04-23 | 11 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda