Medi Nuclear Corp., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Medi Nuclear Corp., Inc.” (first 1981, latest 2008), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| IYT | System, Rebreathing, Radionuclide | 3 | 3 |
| BYP | Mouthpiece, Breathing | 1 | 1 |
| KPT | Calibrator, Dose, Radionuclide | 1 | 1 |
Review panels
- Anesthesiology (5)
- Radiology (4)
Most recent Medi Nuclear Corp., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082541 | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM | CAF | 2008-11-26 | 85 |
| K080969 | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 | CAF | 2008-07-25 | 112 |
| K080657 | NEB-90 LARGE VOLUME MEDICATION NEBULIZER | CAF | 2008-06-30 | 115 |
| K915075 | NEBULIZER (DIRECT PATIENT INTERFACE) | CAF | 1992-07-16 | 251 |
| K865107 | AERO-VENT AEROSOL UNIT | IYT | 1987-10-20 | 293 |
| K865093 | SAFE-T-SHIELD MOUTHPIECE | BYP | 1987-01-15 | 16 |
| K863996 | MODEL XE-103 XENON/MASTER II | IYT | 1986-11-04 | 21 |
| K813379 | RADIONUCLIDE DOSE CALIBRATOR | KPT | 1982-01-22 | 52 |
| K810819 | MEDI/NUCLEAR #XE-102 XENON/MASTER | IYT | 1981-04-14 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Medi Nuclear Corp., 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medi Nuclear Corp., Inc. (a text match, not an official crosswalk):
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.
- Medi Tex, Inc. (4 510(k)s)
- Medi USA, LP (4 510(k)s)
- Medi, Inc. (2 510(k)s)
- Medi Consultants, Inc. (1 510(k)s)
- Medi Legion Sdn.Bhd (1 510(k)s)
- Medi Point, Inc. (1 510(k)s)
- Medi Pure Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medi Nuclear Corp., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Medi Nuclear Corp., Inc.” (first 1981, latest 2008), across 4 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 Medi Nuclear Corp., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi Nuclear Corp., Inc. is 85 days.
Which FDA product codes appear under Medi Nuclear Corp., Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 4); IYT (System, Rebreathing, Radionuclide, 3); BYP (Mouthpiece, Breathing, 1).
Next steps
- See all 9 Medi Nuclear Corp., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Medi Nuclear Corp., 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.