Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Persyst Development Corporation — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
176 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15 | Persyst Development Corporation | 2025-01-22 | 159 | 0 |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | 2022-12-30 | 176 | 0 |
| K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | 2018-11-29 | 108 | 0 |
| K171184 | Persyst Mobile App | Persyst Development Corporation | 2017-09-21 | 150 | 0 |
| K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corporation | 2015-08-12 | 29 | 0 |
| K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | Persyst Development Corporation | 2014-05-19 | 157 | 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