Rinn Corp.: FDA clearances and approvals
Rinn Corp. has 5 FDA 510(k) clearances (first 1978, latest 1993), across 5 product codes in 3 review panels. Median 510(k) review time: 59 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 |
|---|---|---|---|
| EGZ | Holder, Film, X-Ray | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| IWY | Holder, Head, Radiographic | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (2)
- Dental (1)
- General Hospital (1)
Most recent Rinn Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932134 | RINN UNIVERSAL COLLIMATOR | IZX | 1993-07-26 | 84 |
| K913885 | RINN E-Z CAPPER | FMI | 1991-12-13 | 106 |
| K828605 | BEAM LIMITING DEVICE | — | 1983-01-03 | 35 |
| K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | EGZ | 1982-01-29 | 59 |
| K772313 | X-RAY CO-ORDINATOR | IWY | 1978-01-30 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Rinn Corp..
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 Rinn Corp. have?
Rinn Corp. has 5 FDA 510(k) clearances (first 1978, latest 1993), across 5 product codes in 3 review panels.
How long does FDA take to clear Rinn Corp.'s 510(k)s?
The median time from FDA receipt to decision across Rinn Corp.'s cleared 510(k)s is 59 days.
What devices does Rinn Corp. make?
Its most frequent FDA product codes are EGZ (Holder, Film, X-Ray, 1); FMI (Needle, Hypodermic, Single Lumen, 1); IWY (Holder, Head, Radiographic, 1).
Has Rinn Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rinn Corp. Related entities may recall under other names.
Next steps
- See all 5 Rinn Corp. clearances with predicates and recalls
- Run predicate analysis for product code EGZ, Rinn Corp.'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.