# Neurotronics, Inc.

- Location (FDA's records): Gainesville, FL
- FDA decisions: 11 (1997–2026): 11 510(k) clearances
- Names in FDA's records: Neurotronics, Inc. (9); Neurotronics, LLC (2)
- Product codes: OLV (5), GWL (2), OLZ (2), SFK (1), MNR (1)
- 510(k) review time since 2016: median 175 days, against 141 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 11 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nihon Kohden America, Inc.: 3 (https://510kreport.com/company/nihon-kohden-america)
- Nihon Kohden Corporation: 2 (https://510kreport.com/company/nihon-kohden)
- Micro Tronics Corp.: 1 (https://510kreport.com/company/micro-tronics)

## Firms that cite its devices most
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Brainmatterz, LLC: 1 (https://510kreport.com/company/brainmatterz)
- Somnomed Technologies Inc., Doing Business AS Remware: 1 (https://510kreport.com/company/somnomed-technologies-doing-business-as-remware)

## Its most-cited devices
- K142774: Polysmith Sleep System (2015), cited by 3
- K062943: Polysmith Sleep System, Model NTI5498 (2007), cited by 3
- K092699: Nomad Sleep System Recorder, Model PMU800 (2010), cited by 2
- K220631: NomadAir PMU810 (2022), cited by 1
- K971803: Neurotronics Polysomnography System 101 (1997), cited by 1
- K173868: Serenity Body Position Sensor, Serenity RIP Sensors (2018), cited by 1

## Recent decisions
- K261521: Sleep Analysis Module (Oct 9, 2026)
- K251480: PV01 PVDF Effort Sensor (Aug 29, 2025)
- K220631: NomadAir PMU810 (Jul 15, 2022)
- K181709: Serenity Piezo Sensor, Serenity Thermocouple Sensor (Nov 16, 2018)
- K173868: Serenity Body Position Sensor, Serenity RIP Sensors (Jul 2, 2018)
- K161650: Polysmith Sleep System, Model NTI7593 (Jan 19, 2017)
- K142774: Polysmith Sleep System (Feb 18, 2015)
- K131415: Live View Panel (LVP) (Aug 9, 2013)

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