Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Info-Chem — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
38 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810134 | KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM | Info-Chem | 1981-02-26 | 38 | 0 |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | Info-Chem | 1979-09-12 | 30 | 0 |
| K772233 | THERMOMETER RECAL ADAPTER | Info-Chem | 1977-12-20 | 13 | 0 |
| K771080 | STEAM STERILIZATION INDICATOR | Info-Chem | 1977-07-14 | 29 | 0 |
| K771037 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Info-Chem | 1977-06-27 | 17 | 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