Data / Medical devices / United States / Persyst Development LLC
Persyst Development LLC: FDA-registered device maker in Solana Beach, CA, United States, 9 510(k) clearances
Persyst Development LLC is registered with the FDA (registration 2031720) in Solana Beach, CA, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2031720
- FEI number
- 3002624053
- Address
- 420 Stevens Avenue Suite 210, Solana Beach, CA, United States, 92075
- Owner or operator
- PERSYST DEVELOPMENT LLC (9014025)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 23, 2014
- Registered through
- 2027
- Brand names listed
- PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE, Persyst 13 (P13)EEG REVIEW AND ANALYSIS SOFTWARE, Persyst 14 EEG Review and Analysis Software (P14), Persyst 15 EEG Review and Analysis Software, Persyst ESI Powered by Epilog, Persyst ESI powered by Epilog (Persyst Electrical Source Imaging), Persyst Mobile App
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplitude-Integrated Electroencephalograph | OMA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Source Localization Software For Electroencephalograph Or Magnetoencephalograph | OLX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2026 | K252565 | PreOp v3 | OLX | Substantially Equivalent | Clouds of Care | accessdata.fda.gov |
| October 31, 2025 | K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | OMB | Substantially Equivalent | Persyst Development, LLC | accessdata.fda.gov |
| January 22, 2025 | K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | OMB | Substantially Equivalent | Persyst Development Corporation | accessdata.fda.gov |
| December 30, 2022 | K222002 | Persyst 15 EEG Review and Analysis Software | OMB | Substantially Equivalent | Persyst Development Corporation | accessdata.fda.gov |
| November 29, 2018 | K182181 | Persyst 14 EEG Review and Analysis Software | OMB | Substantially Equivalent | Persyst Development Corporation | accessdata.fda.gov |
| January 8, 2018 | K172858 | PreOp | OLX | Substantially Equivalent | Epilog | accessdata.fda.gov |
| September 21, 2017 | K171184 | Persyst Mobile App | OMB | Substantially Equivalent | Persyst Development Corporation | accessdata.fda.gov |
| August 12, 2015 | K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | OMB | Substantially Equivalent | Persyst Development Corporation | accessdata.fda.gov |
| May 19, 2014 | K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | OMB | Substantially Equivalent | Persyst Development Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Automatic Event Detection Software For Full-Montage Electroencephalograph
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Amplitude-Integrated Electroencephalograph
- All makers of Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.