Rigel Medical Electronics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Rigel Medical Electronics, Inc.” (first 1984, latest 1989), across 1 product code in 1 review panel. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Rigel Medical Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884645 | PATIENT MONITOR RIGEL MODEL MULTICARE 429 | DRT | 1989-02-02 | 87 |
| K875160 | RIGEL MODEL MULTICARE 409 | DRT | 1988-06-28 | 196 |
| K850407 | NEONATAL MONITOR 309 | DRT | 1985-04-18 | 73 |
| K850156 | ECG PATIENT MONITOR 301 | DRT | 1985-03-01 | 45 |
| K850155 | ECG PATIENT MONITOR 302 | DRT | 1985-03-01 | 45 |
| K843376 | ECG PATIENT MONITOR | DRT | 1984-12-27 | 121 |
Recalls
openFDA lists no recalls under a recalling firm named Rigel Medical Electronics, 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 Rigel Medical Electronics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Rigel Medical Electronics, Inc.” (first 1984, latest 1989), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rigel Medical Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rigel Medical Electronics, Inc. is 80 days.
Which FDA product codes appear under Rigel Medical Electronics, Inc.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 6).
Next steps
- See all 6 Rigel Medical Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Rigel Medical Electronics, 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.