Barnes-Hind, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Barnes-Hind, Inc.” (first 1978, latest 1985), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | 3 | 3 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 2 | 2 |
| KYC | 1 | 1 | |
| LPN | Accessories, Soft Lens Products | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Barnes-Hind, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852386 | SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT | LPN | 1985-09-04 | 91 |
| K812135 | BARNES-HIND WEEKLY CLEANER | HPX | 1981-08-31 | 34 |
| K811554 | BARNES-HIND SPECTACLE LENS CLEANER | HQG | 1981-07-02 | 30 |
| K810285 | BARNES-HIND ROSE BENGAL OPHTHALMIC STR. | KYC | 1981-04-17 | 74 |
| K800582 | BARNES-HOND HARD CONTACT LENS STOR. CASE | HPX | 1980-03-25 | 11 |
| K791901 | BARNES-HIND WETTING & SOAKING SOLUTION | HQG | 1979-11-16 | 52 |
| K781007 | AUTO-CON | HPX | 1978-06-30 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Barnes-Hind, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Barnes-Hind, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Barnes-Hind, Inc.” (first 1978, latest 1985), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Barnes-Hind, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barnes-Hind, Inc. is 34 days.
Which FDA product codes appear under Barnes-Hind, Inc.?
The most frequent FDA product codes under this applicant name are HPX (Lens, Contact (Polymethylmethacrylate), 3); HQG (Lens, Spectacle, Non-Custom (Prescription), 2); KYC (device, 1).
Next steps
- See all 7 Barnes-Hind, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPX, Barnes-Hind, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.