Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuclear Data, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
416 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891466 | ACCUSPEC THYROID UPTAKE SYSTEM | Nuclear Data, Inc. | 1989-06-06 | 83 | 0 |
| K881383 | ND1100 BONE DENSITY SCANNER | Nuclear Data, Inc. | 1989-05-22 | 416 | 0 |
| K844835 | ND2100 SPINE SCANNER | Nuclear Data, Inc. | 1985-04-18 | 127 | 0 |
| K844766 | ND1100 BONE DENSITY SCANNER | Nuclear Data, Inc. | 1985-04-16 | 130 | 0 |
| K843349 | ND3100 VIDEO IMAGER | Nuclear Data, Inc. | 1984-12-17 | 112 | 0 |
| K841440 | ND62T THYROID UPTAKE SYSTEM | Nuclear Data, Inc. | 1984-06-05 | 60 | 0 |
| K841352 | ND1200 RIA COUNTER | Nuclear Data, Inc. | 1984-05-02 | 30 | 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