Walmart Stores: FDA clearances and approvals
Walmart Stores has 5 FDA 510(k) clearances (first 1994, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time: 38 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Walmart Stores 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954639 | SUNGLASSES | HQY | 1995-10-25 | 15 |
| K945819 | SUNGLASSES | HQY | 1995-01-05 | 38 |
| K945818 | SUNGLASSES | HQY | 1995-01-05 | 38 |
| K945817 | SUNGLASSES | HQY | 1995-01-05 | 38 |
| K941680 | SUNGLASSES | HQY | 1994-05-09 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Walmart Stores.
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 Walmart Stores have?
Walmart Stores has 5 FDA 510(k) clearances (first 1994, latest 1995), across 1 product code in 1 review panel.
How long does FDA take to clear Walmart Stores's 510(k)s?
The median time from FDA receipt to decision across Walmart Stores's cleared 510(k)s is 38 days.
What devices does Walmart Stores make?
Its most frequent FDA product codes are HQY (Sunglasses (Non-Prescription Including Photosensitive), 5).
Has Walmart Stores had device recalls?
openFDA lists no recalls under a recalling firm name matching Walmart Stores. Related entities may recall under other names.
Next steps
- See all 5 Walmart Stores clearances with predicates and recalls
- Run predicate analysis for product code HQY, Walmart Stores'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.