Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zynex Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
242 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 | 91 | 0 |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023-06-16 | 242 | 0 |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020-02-21 | 241 | 0 |
| K121820 | INWAVE | Zynex Medical, Inc. | 2012-08-24 | 64 | 0 |
| K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | Zynex Medical, Inc. | 2011-09-20 | 138 | 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