Ja-Ru, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ja-Ru, Inc.” (first 1993, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 70 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) | 5 | 5 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Ja-Ru, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941682 | COOL KIDS BEADS AND SHADES | HQY | 1994-05-17 | 42 |
| K935919 | SUNGLASSES | HQG | 1994-02-16 | 70 |
| K934402 | COOL KIDS MIRROR SHADES | HQY | 1994-01-25 | 138 |
| K935165 | BIKER MICE SUNGLASSES | HQY | 1994-01-06 | 69 |
| K934852 | COOL KIDS HIP SHADES | HQY | 1993-12-08 | 57 |
| K931389 | ITEM # 754 HOT FLIP SHADES | HQY | 1993-10-06 | 202 |
Recalls
openFDA lists no recalls under a recalling firm named Ja-Ru, 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 Ja-Ru, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ja-Ru, Inc.” (first 1993, latest 1994), across 2 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 Ja-Ru, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ja-Ru, Inc. is 70 days.
Which FDA product codes appear under Ja-Ru, Inc.?
The most frequent FDA product codes under this applicant name are HQY (Sunglasses (Non-Prescription Including Photosensitive), 5); HQG (Lens, Spectacle, Non-Custom (Prescription), 1).
Next steps
- See all 6 Ja-Ru, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQY, Ja-Ru, 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.