Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurotronics, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
223 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | 2022-07-15 | 133 | 0 |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | 2018-11-16 | 141 | 0 |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018-07-02 | 194 | 0 |
| K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | 2017-01-19 | 218 | 0 |
| K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015-02-18 | 145 | 0 |
| K131415 | LIVE VIEW PANEL (LVP) | Neurotronics, Inc. | 2013-08-09 | 85 | 0 |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | Neurotronics, Inc. | 2010-03-18 | 197 | 0 |
| K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | Neurotronics, Inc. | 2007-05-09 | 223 | 0 |
| K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 | Neurotronics, Inc. | 1997-11-12 | 184 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda