Neurotronics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Neurotronics, Inc.” (first 1997, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 164 days. Since 2017 the median was 141 days, against 181 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 85 |
| 2014 | 0 | — |
| 2015 | 1 | 145 |
| 2016 | 0 | — |
| 2017 | 1 | 218 |
| 2018 | 2 | 168 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 133 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 108 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neurotronics, Inc. took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | 5 | 5 |
| GWL | Amplifier, Physiological Signal | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 | 1 |
| SFK | Respiratory Effort Belt For Polysomnography | 1 | 1 |
Review panels
- Neurology (8)
- Anesthesiology (2)
Most recent Neurotronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251480 | PV01 PVDF Effort Sensor | SFK | 2025-08-29 | 108 |
| K220631 | NomadAir PMU810 | GWL | 2022-07-15 | 133 |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | OLV | 2018-11-16 | 141 |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | OLV | 2018-07-02 | 194 |
| K161650 | Polysmith Sleep System, Model NTI7593 | OLV | 2017-01-19 | 218 |
| K142774 | Polysmith Sleep System | OLV | 2015-02-18 | 145 |
| K131415 | LIVE VIEW PANEL (LVP) | OLV | 2013-08-09 | 85 |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | GWL | 2010-03-18 | 197 |
| K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | OLZ | 2007-05-09 | 223 |
| K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 | MNR | 1997-11-12 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Neurotronics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurotronics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Neurotronics, Inc.” (first 1997, latest 2025), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neurotronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurotronics, Inc. is 164 days. Since 2017: 141 days, versus 181 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neurotronics, Inc.?
The most frequent FDA product codes under this applicant name are OLV (Standard Polysomnograph With Electroencephalograph, 5); GWL (Amplifier, Physiological Signal, 2); MNR (Ventilatory Effort Recorder, 1).
Next steps
- See all 10 Neurotronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLV, Neurotronics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.