Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kem Medical Products Corp. · 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) |
|---|---|---|---|---|---|
| K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | 2019-03-01 | 239 | 0 |
| K802228 | BIOLOGICAL INDICATOR - KEMMED & BIOSURE | Kem Medical Products Corp. | 1980-12-09 | 90 | 0 |
| K802229 | CHEMICAL INDICATOR - KEM MED & BIO SURE | Kem Medical Products Corp. | 1980-12-09 | 90 | 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