Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
H & C Chemical, 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) |
|---|---|---|---|---|---|
| K941134 | EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT | H & C Chemical, Inc. | 1994-05-16 | 68 | 0 |
| K941094 | INSUFFLATION TUBING & FILTER | H & C Chemical, Inc. | 1994-05-10 | 63 | 0 |
| K934528 | 2C LENS FOG REDUCTION & CLEANING DEVICE | H & C Chemical, Inc. | 1994-02-16 | 152 | 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