J & B Assoc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “J & B Assoc.” (first 1990, latest 1990), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 10 | 10 |
Review panels
- Ophthalmic (10)
Most recent J & B Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900529 | MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES | HQY | 1990-05-03 | 90 |
| K900528 | MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES | HQY | 1990-05-03 | 90 |
| K900527 | MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES | HQY | 1990-05-03 | 90 |
| K900526 | MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS | HQY | 1990-05-03 | 90 |
| K900524 | MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER | HQY | 1990-05-03 | 90 |
| K900522 | MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS | HQY | 1990-05-03 | 90 |
| K900521 | MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER | HQY | 1990-05-03 | 90 |
| K900520 | MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS | HQY | 1990-05-03 | 90 |
| K900525 | MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE | HQY | 1990-02-27 | 25 |
| K900523 | MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. | HQY | 1990-02-27 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named J & B Assoc..
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 J & B Assoc.?
FDA lists 10 510(k) clearances under the applicant name “J & B Assoc.” (first 1990, latest 1990), across 1 product code 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 J & B Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J & B Assoc. is 90 days.
Which FDA product codes appear under J & B Assoc.?
The most frequent FDA product codes under this applicant name are HQY (Sunglasses (Non-Prescription Including Photosensitive), 10).
Next steps
- See all 10 J & B Assoc. clearances with predicates and recalls
- Run predicate analysis for product code HQY, J & B Assoc.'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.