Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hi-Dow International, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
245 daysmedian FDA review time
276 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | Hi-Dow International, Inc. | 2024-01-19 | 88 | 0 |
| K210383 | Wrap Accessory Electrodes | Hi-Dow International, Inc. | 2021-11-12 | 276 | 0 |
| K202337 | Pulsed electromagnetic field wrap | Hi-Dow International, Inc. | 2020-12-15 | 120 | 0 |
| K190617 | Wrap accessory electrodes | Hi-Dow International, Inc. | 2019-07-02 | 113 | 0 |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | Hi-Dow International, Inc. | 2017-08-04 | 245 | 0 |
| K102598 | HI-DOW-XP | Hi-Dow International, Inc. | 2011-05-13 | 245 | 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