# Nico Corporation

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 9 (2012–2024): 9 510(k) clearances
- Product codes: GEI (5), GZT (3), QFX (1)
- 510(k) review time since 2016: median 27 days, against 108 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Promex, Inc.: 2 (https://510kreport.com/company/promex)
- Kirwan Surgical Products, Inc.: 1 (https://510kreport.com/company/kirwan-surgical-products)
- Silverglide Surgical Technologies: 1 (https://510kreport.com/company/silverglide-surgical-technologies)
- Vycor Medical, Inc.: 1 (https://510kreport.com/company/vycor-medical)
- Leica Microsystems (Schweiz) AG: 1 (https://510kreport.com/company/leica-microsystems-schweiz)
- Linvatec Corp.: 1 (https://510kreport.com/company/linvatec)

## Firms that cite its devices most
- Rebound Therapeutics: 2 (https://510kreport.com/company/rebound-therapeutics)
- Minnetronix Neuro, Inc.: 1 (https://510kreport.com/company/minnetronix-neuro)

## Its most-cited devices
- K120691: Brain Port (2012), cited by 2
- K161307: NICO Myriad (2016), cited by 2
- K150378: NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (2015), cited by 1
- K150993: NICO TRIOwand (2015), cited by 1
- K172433: NICO BrainPath (2017), cited by 1
- K182340: NICO Myriad (2018), cited by 1

## Recent decisions
- K232567: Myriad SPECTRA Light Source (Mar 14, 2024)
- K191599: NICO Myriad NOVUS (Sep 13, 2019)
- K182340: NICO Myriad (Sep 20, 2018)
- K172433: NICO BrainPath (Sep 7, 2017)
- K161307: NICO Myriad (Dec 21, 2016)
- K162075: NICO TRIOwand (Aug 11, 2016)
- K150378: NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (Jun 12, 2015)
- K150993: NICO TRIOwand (Apr 23, 2015)

Source page: https://510kreport.com/company/nico