Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Huntington Laboratories, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
71 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960580 | BEAUCOUP GENERAL PURPOSE DISINFECTANT | Huntington Laboratories, Inc. | 1996-03-12 | 29 | 0 |
| K960582 | ASCEND GENERAL PURPOSE DISINFECTANT | Huntington Laboratories, Inc. | 1996-03-12 | 29 | 0 |
| K960583 | MATAR GENERAL PURPOSE DISINFECTANT | Huntington Laboratories, Inc. | 1996-03-12 | 29 | 0 |
| K953011 | FORMULATION HWS-64 EPA REG. NO. 47371-131 | Huntington Laboratories, Inc. | 1995-08-11 | 44 | 0 |
| K953010 | FORMULATION HWS-256 EPA REG. NO. 47371-129 | Huntington Laboratories, Inc. | 1995-08-11 | 44 | 0 |
| K953009 | FORMULATION HWS-128 EPA REG. NO. 47371-130 | Huntington Laboratories, Inc. | 1995-08-11 | 44 | 0 |
| K853653 | SANA-LUBE | Huntington Laboratories, Inc. | 1985-11-13 | 71 | 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