Almen Laboratories, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Almen Laboratories, Inc.” (first 2008, latest 2008), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 276 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MYN | Analyzer, Medical Image | 1 | 0 |
Review panels
- Radiology (2)
Most recent Almen Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072258 | BI-RADS COMPANION | LLZ | 2008-05-16 | 276 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100007 | PMA | BREAST COMPANION SOFTWARE SYSTEM | 2012-02-10 |
Recalls
openFDA lists no recalls under a recalling firm named Almen Laboratories, 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 Almen Laboratories, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Almen Laboratories, Inc.” (first 2008, latest 2008), plus 1 PMA 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 Almen Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Almen Laboratories, Inc. is 276 days.
Which FDA product codes appear under Almen Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 1); MYN (Analyzer, Medical Image, 1).
Next steps
- See all 1 Almen Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Almen Laboratories, 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.