Persyst Development LLC
Solana Beach, CA, US
PERSYST DEVELOPMENT LLC appears in FDA device records in Solana Beach, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Persyst Development LLC between 1998 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2001 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | OMB | Substantially Equivalent | |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | OMB | Substantially Equivalent | |
| K222002 | Persyst 15 EEG Review and Analysis Software | OMB | Substantially Equivalent | |
| K182181 | Persyst 14 EEG Review and Analysis Software | OMB | Substantially Equivalent | |
| K171184 | Persyst Mobile App | OMB | Substantially Equivalent | |
| K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | OMB | Substantially Equivalent | |
| K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | OMB | Substantially Equivalent | |
| K132306 | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE | OMB | Substantially Equivalent | |
| K103103 | PRESSON ELECTRODE | GXZ | Substantially Equivalent | |
| K011397 | PERSYST REVEAL | OMB | Substantially Equivalent | |
| K974718 | PERSYST PRISM | GWS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031720 | 3002624053 | PERSYST DEVELOPMENT LLC | 420 Stevens Avenue, Solana Beach, CA 92075 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OMAAmplitude-Integrated Electroencephalograph
- GWSAnalyzer, Spectrum, Electroencephalogram Signal
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph
- GXZElectrode, Needle
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain