510(k) Report

FDA applicant

Nico Corporation

Indianapolis, IN9 decisions2012–20247 recalls

FDA records 9 decisions for Nico Corporation (Indianapolis, IN) from 2012 to 2024: 9 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GZT (Retractor, Self-Retaining, For Neurosurgery). Since 2016 its 510(k)s took a median of 27 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 of them its own earlier devices. 7 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Nico Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2012: 12015: 22016: 22017: 12018: 12019: 12024: 1
2012high 2 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2025

2012: 22021: 22025: 3
2012high 3 (2025) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Nico Corporation by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nico Corporation’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions
  • GZTRetractor, Self-Retaining, For Neurosurgery3decisions
  • QFXDiagnostic Neurosurgical Microscope Filter1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 27 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K120691Brain PortNico Corporation · 20122cite it
  • K161307NICO MyriadNico Corporation · 20162cite it
  • K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 20151cites it
  • K150993NICO TRIOwandNico Corporation · 20151cites it
  • K172433NICO BrainPathNico Corporation · 20171cites it
  • K182340NICO MyriadNico Corporation · 20181cites it

What has FDA decided for it lately?

  • K232567Myriad SPECTRA Light SourceNico Corporation · 20241 recall
  • K191599NICO Myriad NOVUSNico Corporation · 20195 recalls
  • K182340NICO MyriadNico Corporation · 2018
  • K172433NICO BrainPathNico Corporation · 2017
  • K161307NICO MyriadNico Corporation · 2016
  • K162075NICO TRIOwandNico Corporation · 2016
  • K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation · 2015
  • K150993NICO TRIOwandNico Corporation · 2015

All 9 as Nico Corporation →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K191599NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13…Oct 31, 2025Class II
  • K191599NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product…Oct 31, 2025Class II
  • K191599NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook -…Oct 31, 2025Class II
  • K191599NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF…Apr 30, 2021Class II
  • K191599Myriad-LX Light Source-for delivery of light to the surgical field to enhance…Apr 30, 2021Class II
  • K12069113.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that…Jul 17, 2012Class II

Other applicant names beginning “Nico”

FDA records each applicant name separately; these may or may not be the same firm.

Nico-Lab B.V. 2Nico Metal Products Corp. 1