Lunar Radiation Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Lunar Radiation Corp.” (first 1980, latest 1988), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Review panels
- Radiology (5)
- Cardiovascular (1)
Most recent Lunar Radiation Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873296 | DPX BONE DENSITOMETER | KGI | 1988-06-06 | 294 |
| K810159 | BONE MINERAL ANALYZER CONTROLLER | KGI | 1981-02-12 | 22 |
| K810140 | DUAL-PHOTON TOTAL BODY BONE MINERAL ANA | KGI | 1981-02-12 | 22 |
| K802181 | WISCONSIN BONE MINERAL ANALYZER | KGI | 1980-12-31 | 113 |
| K802180 | WISCONSIN DUAL-PHOTON BONE ANALYZER | KGI | 1980-12-31 | 113 |
| K802182 | WISCONSIN HEART RATE MONITOR | DRT | 1980-10-31 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Lunar Radiation Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lunar Corp. (29 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lunar Radiation Corp.?
FDA lists 6 510(k) clearances under the applicant name “Lunar Radiation Corp.” (first 1980, latest 1988), across 2 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 Lunar Radiation Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lunar Radiation Corp. is 82 days.
Which FDA product codes appear under Lunar Radiation Corp.?
The most frequent FDA product codes under this applicant name are KGI (Densitometer, Bone, 5); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 6 Lunar Radiation Corp. clearances with predicates and recalls
- Run predicate analysis for product code KGI, Lunar Radiation Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.