Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuclear Medical Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
92 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821145 | I-DHEA-SULFATE RIA KIT 125 | Nuclear Medical Systems, Inc. | 1982-05-14 | 23 | 0 |
| K791582 | CARDIO CK-B RIA KIT | Nuclear Medical Systems, Inc. | 1979-11-15 | 92 | 0 |
| K791735 | PAP RIA KIT | Nuclear Medical Systems, Inc. | 1979-11-15 | 77 | 0 |
| K780679 | B-HCG-RIA | Nuclear Medical Systems, Inc. | 1978-06-14 | 51 | 0 |
| K771378 | NEO TSH-RIA KIT | Nuclear Medical Systems, Inc. | 1977-10-18 | 90 | 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