Rudolph Beaver, Inc.: FDA clearances and approvals
Rudolph Beaver, Inc. has 6 FDA 510(k) clearances (first 1985, latest 1988), across 4 product codes in 2 review panels. Median 510(k) review time: 40 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | 3 | 3 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HNY | Cystotome | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- Ophthalmic (5)
- Orthopedic (1)
Most recent Rudolph Beaver, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883361 | ARTHRO-TRAC(TM) | HRX | 1988-10-13 | 65 |
| K875030 | OCU-1 | HMX | 1988-05-03 | 148 |
| K862709 | MECHANICAL CYSTITOME | HNY | 1986-08-01 | 16 |
| K860305 | BEAVER MICRO-GEM GAUGE BLOCK | HNN | 1986-02-12 | 15 |
| K852828 | BEAVER R-K KNIFE | HNN | 1985-11-04 | 125 |
| K853129 | BEAVER MULTIPURPOSE SAPPHIRE KNIFE | HNN | 1985-08-06 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Rudolph Beaver, Inc..
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 Rudolph Beaver, Inc. have?
Rudolph Beaver, Inc. has 6 FDA 510(k) clearances (first 1985, latest 1988), across 4 product codes in 2 review panels.
How long does FDA take to clear Rudolph Beaver, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Rudolph Beaver, Inc.'s cleared 510(k)s is 40 days.
What devices does Rudolph Beaver, Inc. make?
Its most frequent FDA product codes are HNN (Knife, Ophthalmic, 3); HMX (Cannula, Ophthalmic, 1); HNY (Cystotome, 1).
Has Rudolph Beaver, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rudolph Beaver, Inc. Related entities may recall under other names.
Next steps
- See all 6 Rudolph Beaver, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNN, Rudolph Beaver, Inc.'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.