H.W. Andersen Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “H.W. Andersen Products, Inc.” (first 1987, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | 3 | 3 |
| BSS | Tube, Nasogastric | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
Review panels
Most recent H.W. Andersen Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935688 | AN-10S ANDERSEN TUBE WITH STYLET | BSS | 1994-12-30 | 396 |
| K872458 | AN3200 DOUBILET DRAIN | FGE | 1987-09-21 | 90 |
| K872460 | AN3000 MAHONEY DRAIN | GBS | 1987-07-23 | 30 |
| K872459 | AN3100 MULHOLLAND DRAIN | GBS | 1987-07-21 | 28 |
| K872457 | AN3500 WORTH DRAIN | GBS | 1987-07-21 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named H.W. Andersen Products, 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 H.W. Andersen Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “H.W. Andersen Products, Inc.” (first 1987, latest 1994), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by H.W. Andersen Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name H.W. Andersen Products, Inc. is 30 days.
Which FDA product codes appear under H.W. Andersen Products, Inc.?
The most frequent FDA product codes under this applicant name are GBS (Catheter, Ventricular, General & Plastic Surgery, 3); BSS (Tube, Nasogastric, 1); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 5 H.W. Andersen Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GBS, H.W. Andersen Products, 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.