510(k) Report

FDA applicant

Neocoil, LLC

Pewaukee, WI21 decisions2007–20262 recalls

FDA records 21 decisions for Neocoil, LLC (Pewaukee, WI) from 2007 to 2026: 21 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 53 days from receipt to decision, against 71 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 12 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Neocoil”.

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 Neocoil, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2007: 52010: 22012: 22013: 22014: 22016: 12017: 12018: 22020: 12022: 22026 (partial year): 1
2007high 5 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2016

2015: 12016: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Neocoil, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty18decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 53 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 71 days; 6 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 12 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.

  • K1213621.5T 16CH Flex Speeder LargeNeocoil, LLC · 20124cite it
  • K1733773.0T 16ch Breast CoilNeocoil, LLC · 20172cite it
  • K1134741.5T Gem Flex CoilNeocoil, LLC · 20122cite it
  • K101632MetaflexcoilNeocoil, LLC · 20102cite it
  • K071311Neocoil 1.5T 8-Channel Shoulder Array CoilNeocoil · 20071cites it
  • K071611Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil · 20071cites it

What has FDA decided for it lately?

  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil…Neocoil, LLC · 2022
  • K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch…Neocoil, LLC · 2022
  • K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC · 2020
  • K1829581.5T 16ch Breast CoilNeocoil, LLC · 2018
  • K173409Wireless Audio SystemNeocoil, LLC · 2018
  • K1733773.0T 16ch Breast CoilNeocoil, LLC · 2017
  • K160350ECG CT Gating DeviceNeocoil, LLC · 2016

All 17 as Neocoil, LLC →All 4 as Neocoil →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K1418323T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems…Jun 17, 2016Class II
  • K103342NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil…Dec 18, 2015Class II