Bay Labs, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Bay Labs, Inc.” (first 2018, latest 2018), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 184 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 |
|---|---|---|
| 2018 | 1 | 184 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bay Labs, Inc. took a median 184 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 1 | 0 |
Review panels
- Radiology (2)
Most recent Bay Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173780 | EchoMD Automated Ejection Fraction Software | LLZ | 2018-06-14 | 184 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190040 | De Novo | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 2020-02-07 |
Recalls
openFDA lists no recalls under a recalling firm named Bay Labs, 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 Bay Labs, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Bay Labs, Inc.” (first 2018, latest 2018), plus 1 De Novo decision, 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 Bay Labs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bay Labs, Inc. is 184 days.
Which FDA product codes appear under Bay Labs, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 1); QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence, 1).
Next steps
- See all 1 Bay Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Bay Labs, 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.