Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtech Products, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
198 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242803 | Compound W Skin Tag Remover | Medtech Products, Inc. | 2024-11-06 | 50 | 0 |
| K202974 | DenTek Fresh Protect Dental Guard | Medtech Products, Inc. | 2020-12-22 | 83 | 0 |
| K180933 | DenTek Ultimate Dental Guard | Medtech Products, Inc. | 2018-09-17 | 160 | 0 |
| K172373 | Compound W Nitro-Freeze | Medtech Products, Inc. | 2017-11-02 | 87 | 0 |
| K163401 | Nix Ultra Lice Treatment Kit | Medtech Products, Inc. | 2017-03-21 | 106 | 0 |
| K161294 | Compound W Wart Removal System Dual Power | Medtech Products, Inc. | 2016-09-15 | 129 | 0 |
| K853141 | ACCESS DIGIWIPE SYSTEM | Medtech Products, Inc. | 1985-11-18 | 117 | 0 |
| K851034 | NOVATHERM | Medtech Products, Inc. | 1985-09-27 | 198 | 0 |
| K843601 | ACCESS HEMAWIPE | Medtech Products, Inc. | 1985-01-04 | 114 | 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