Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Neuro Kinetics, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmo | Neuro Kinetics, Inc. | 2018-07-24 | 97 | 0 |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | 2017-11-22 | 152 | 0 |
| K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015-07-08 | 201 | 1 |
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