Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi Nuclear Corp., Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
293 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082541 | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM | Medi Nuclear Corp., Inc. | 2008-11-26 | 85 | 0 |
| K080969 | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 | Medi Nuclear Corp., Inc. | 2008-07-25 | 112 | 0 |
| K080657 | NEB-90 LARGE VOLUME MEDICATION NEBULIZER | Medi Nuclear Corp., Inc. | 2008-06-30 | 115 | 0 |
| K915075 | NEBULIZER (DIRECT PATIENT INTERFACE) | Medi Nuclear Corp., Inc. | 1992-07-16 | 251 | 0 |
| K865107 | AERO-VENT AEROSOL UNIT | Medi Nuclear Corp., Inc. | 1987-10-20 | 293 | 0 |
| K865093 | SAFE-T-SHIELD MOUTHPIECE | Medi Nuclear Corp., Inc. | 1987-01-15 | 16 | 0 |
| K863996 | MODEL XE-103 XENON/MASTER II | Medi Nuclear Corp., Inc. | 1986-11-04 | 21 | 0 |
| K813379 | RADIONUCLIDE DOSE CALIBRATOR | Medi Nuclear Corp., Inc. | 1982-01-22 | 52 | 0 |
| K810819 | MEDI/NUCLEAR #XE-102 XENON/MASTER | Medi Nuclear Corp., Inc. | 1981-04-14 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda