Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Staodynamics, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
122 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852298 | TENS-AID STERILE ELECTRODES FOR POST-OP TENS | Staodynamics, Inc. | 1985-06-24 | 26 | 0 |
| K843964 | TENS-AID PREMIUM ELECTRODES | Staodynamics, Inc. | 1985-02-25 | 137 | 0 |
| K832988 | STAODYN EMS/PLUS | Staodynamics, Inc. | 1983-11-22 | 82 | 0 |
| K813283 | 10D (TENS DEVICE) | Staodynamics, Inc. | 1982-02-10 | 79 | 0 |
| K813098 | TENS DEVICE | Staodynamics, Inc. | 1981-11-20 | 17 | 0 |
| K811345 | INSIGHT | Staodynamics, Inc. | 1981-07-10 | 59 | 0 |
| K792529 | POINT LOCATOR STIMULATOR | Staodynamics, Inc. | 1980-02-26 | 81 | 0 |
| K792501 | PLS MINI | Staodynamics, Inc. | 1980-02-26 | 84 | 0 |
| K800068 | ELECTRICAL MUSCLE STIMULATOR (EMS) | Staodynamics, Inc. | 1980-02-05 | 25 | 0 |
| K792502 | TENS 4100 | Staodynamics, Inc. | 1979-12-18 | 14 | 0 |
| K792474 | TENS 4500 | Staodynamics, Inc. | 1979-12-13 | 10 | 0 |
| K791087 | PORTABLE PULSE GALVANIC STIMULATOR | Staodynamics, Inc. | 1979-10-12 | 122 | 0 |
| K790542 | ELECTRODES, STAODERM STERILE | Staodynamics, Inc. | 1979-05-23 | 62 | 0 |
| K790904 | STAO-HOTPACK | Staodynamics, Inc. | 1979-05-18 | 7 | 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