Humboldt Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Humboldt Products” (first 1980, latest 1984), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 2 | 2 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| GDG | Hook, Surgical, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Humboldt Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832540 | DRUMTO STAPES PROSTHESIS | ETB | 1984-01-03 | 158 |
| K823483 | STAINLESS STEEL PISTONS | ETB | 1982-12-09 | 16 |
| K813616 | TEKNA MED MYRINGOTOMY DISPOS-OTO KIT | ETD | 1982-01-22 | 24 |
| K812562 | SURGICAL RETRACTOR & ELASTIC STAYS, DISP | GDG | 1981-10-02 | 24 |
| K802587 | OTOLOGICAL VENTILATION TUBES | ETD | 1980-11-12 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Humboldt Products.
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 Humboldt Products?
FDA lists 5 510(k) clearances under the applicant name “Humboldt Products” (first 1980, latest 1984), 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 Humboldt Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Humboldt Products is 24 days.
Which FDA product codes appear under Humboldt Products?
The most frequent FDA product codes under this applicant name are ETB (Prosthesis, Partial Ossicular Replacement, 2); ETD (Tube, Tympanostomy, 2); GDG (Hook, Surgical, General & Plastic Surgery, 1).
Next steps
- See all 5 Humboldt Products clearances with predicates and recalls
- Run predicate analysis for product code ETB, Humboldt Products'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.