Huntington Laboratories, Inc.: FDA clearances and approvals
Huntington Laboratories, Inc. has 7 FDA 510(k) clearances (first 1985, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time: 44 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | 6 | 6 |
| KMJ | Lubricant, Patient | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Huntington Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960583 | MATAR GENERAL PURPOSE DISINFECTANT | LRJ | 1996-03-12 | 29 |
| K960582 | ASCEND GENERAL PURPOSE DISINFECTANT | LRJ | 1996-03-12 | 29 |
| K960580 | BEAUCOUP GENERAL PURPOSE DISINFECTANT | LRJ | 1996-03-12 | 29 |
| K953011 | FORMULATION HWS-64 EPA REG. NO. 47371-131 | LRJ | 1995-08-11 | 44 |
| K953010 | FORMULATION HWS-256 EPA REG. NO. 47371-129 | LRJ | 1995-08-11 | 44 |
| K953009 | FORMULATION HWS-128 EPA REG. NO. 47371-130 | LRJ | 1995-08-11 | 44 |
| K853653 | SANA-LUBE | KMJ | 1985-11-13 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Huntington Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Huntington Laboratories, Inc. have?
Huntington Laboratories, Inc. has 7 FDA 510(k) clearances (first 1985, latest 1996), across 2 product codes in 1 review panel.
How long does FDA take to clear Huntington Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Huntington Laboratories, Inc.'s cleared 510(k)s is 44 days.
What devices does Huntington Laboratories, Inc. make?
Its most frequent FDA product codes are LRJ (Disinfectant, Medical Devices, 6); KMJ (Lubricant, Patient, 1).
Has Huntington Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Huntington Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 7 Huntington Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRJ, Huntington Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.