Persyst Development Corporation: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Persyst Development Corporation” (first 1998, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 150 days, against 150 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 120 |
| 2014 | 1 | 157 |
| 2015 | 1 | 29 |
| 2016 | 0 | — |
| 2017 | 1 | 150 |
| 2018 | 1 | 108 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 176 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 136 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Persyst Development Corporation took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 9 | 9 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
Review panels
- Neurology (11)
Most recent Persyst Development Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | OMB | 2025-10-31 | 113 |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | OMB | 2025-01-22 | 159 |
| K222002 | Persyst 15 EEG Review and Analysis Software | OMB | 2022-12-30 | 176 |
| K182181 | Persyst 14 EEG Review and Analysis Software | OMB | 2018-11-29 | 108 |
| K171184 | Persyst Mobile App | OMB | 2017-09-21 | 150 |
| K151929 | PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE | OMB | 2015-08-12 | 29 |
| K133793 | PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE | OMB | 2014-05-19 | 157 |
| K132306 | PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE | OMB | 2013-11-21 | 120 |
| K103103 | PRESSON ELECTRODE | GXZ | 2011-12-08 | 414 |
| K011397 | PERSYST REVEAL | OMB | 2001-08-03 | 88 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Persyst Development Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Persyst Consulting Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Persyst Development Corporation?
FDA lists 11 510(k) clearances under the applicant name “Persyst Development Corporation” (first 1998, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Persyst Development Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Persyst Development Corporation is 120 days. Since 2017: 150 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Persyst Development Corporation?
The most frequent FDA product codes under this applicant name are OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph, 9); GWS (Analyzer, Spectrum, Electroencephalogram Signal, 1); GXZ (Electrode, Needle, 1).
Next steps
- See all 11 Persyst Development Corporation clearances with predicates and recalls
- Run predicate analysis for product code OMB, Persyst Development Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.