510(k) Report

FDA applicant

Mr Instruments, Inc.

Minnetonka, MN7 decisions2004–20171 recall

FDA records 7 decisions for Mr Instruments, Inc. (Minnetonka, MN) from 2004 to 2017: 7 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 10 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Mr Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12008: 12011: 12013: 12017: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mr Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty7decisions

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040937Tem 3000 Head CoilMr Instruments, Inc. · 20041cites it
  • K130706Duoflex Coil Suite (1.5T)Mr Instruments, Inc. · 20131cites it

What has FDA decided for it lately?

  • K173290DuoFLEX Coil SuiteMr Instruments, Inc. · 2017
  • K130706Duoflex Coil Suite (1.5T)Mr Instruments, Inc. · 20131 recall
  • K110591MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel Head CoilMr Instruments, Inc. · 2011
  • K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008
  • K072931MC 3003G-32R Head CoilMr Instruments, Inc. · 2007
  • K052200Tem 3000 Head CoilMr Instruments, Inc. · 2005
  • K040937Tem 3000 Head CoilMr Instruments, Inc. · 2004

All 7 as Mr Instruments, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090196Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in…May 23, 2017Class II