Rozinn Electronics, Inc.: FDA clearances and approvals
Rozinn Electronics, Inc. has 6 FDA 510(k) clearances (first 1990, latest 2006), across 4 product codes in 1 review panel. Median 510(k) review time: 78 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Rozinn Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061780 | TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + | DXH | 2006-09-15 | 81 |
| K042463 | HOLTER PLUS | DQK | 2004-09-22 | 9 |
| K022540 | CARDIO ID+(RZ153+) | DSH | 2002-10-24 | 84 |
| K021517 | ABP FOR WINDOWS | DSK | 2002-07-24 | 75 |
| K020213 | NETLINK/NETSCAN | DXH | 2002-04-05 | 73 |
| K903331 | ROZINN 151 | DSH | 1990-10-22 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Rozinn Electronics, 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 Rozinn Electronics, Inc. have?
Rozinn Electronics, Inc. has 6 FDA 510(k) clearances (first 1990, latest 2006), across 4 product codes in 1 review panel.
How long does FDA take to clear Rozinn Electronics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Rozinn Electronics, Inc.'s cleared 510(k)s is 78 days.
What devices does Rozinn Electronics, Inc. make?
Its most frequent FDA product codes are DSH (Recorder, Magnetic Tape, Medical, 2); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 2); DQK (Computer, Diagnostic, Programmable, 1).
Has Rozinn Electronics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rozinn Electronics, Inc. Related entities may recall under other names.
Next steps
- See all 6 Rozinn Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSH, Rozinn Electronics, 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.