Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dyansys, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
134 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221425 | Primary Relief | Dyansys, Inc. | 2022-09-13 | 120 | 0 |
| K221231 | Drug Relief v1 | Dyansys, Inc. | 2022-06-06 | 38 | 0 |
| K220397 | ANSiStim-PP | Dyansys, Inc. | 2022-05-12 | 90 | 0 |
| K213188 | Primary Relief | Dyansys, Inc. | 2022-01-31 | 124 | 0 |
| K212859 | First Relief | Dyansys, Inc. | 2021-12-20 | 103 | 0 |
| K211971 | Drug Relief v1 | Dyansys, Inc. | 2021-11-05 | 134 | 0 |
| K202940 | First Relief v1 | Dyansys, Inc. | 2020-12-29 | 90 | 0 |
| K173861 | Drug Relief | Dyansys, Inc. | 2018-05-02 | 133 | 0 |
| K170391 | ANSiStim-PP | Dyansys, Inc. | 2017-03-09 | 29 | 0 |
| K141168 | ANSISTIM | Dyansys, Inc. | 2015-05-15 | 374 | 0 |
| K091397 | ECSCOPE 200 | Dyansys, Inc. | 2009-07-08 | 57 | 0 |
| K091358 | ECSCOPE 100 | Dyansys, Inc. | 2009-05-28 | 20 | 0 |
| K080036 | PORTABLE ECSCOPE 12I | Dyansys, Inc. | 2008-01-16 | 9 | 0 |
| K071168 | THE PORTABLE ANSISCOPE | Dyansys, Inc. | 2007-08-31 | 126 | 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