Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Koalaty Products, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102014 | TENS STIMULATOR, MODELS 2800 AND 3000 | Koalaty Products, Inc. | 2010-08-31 | 46 | 0 |
| K080661 | MODELS TENS 7000, EMS 7500 AND TWIN STIM | Koalaty Products, Inc. | 2008-03-24 | 14 | 0 |
| K072795 | MODELS EMS 5.0, EMS 5.1 | Koalaty Products, Inc. | 2007-11-27 | 57 | 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