Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cambridge Nuclear Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
60 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811380 | ESTRIOL KIT | Cambridge Nuclear Corp. | 1981-06-09 | 25 | 0 |
| K810804 | PROGESTERONE KIT | Cambridge Nuclear Corp. | 1981-04-01 | 8 | 0 |
| K790362 | I BRADYKININ & ANTI-BRADYKININ ANTISERUM | Cambridge Nuclear Corp. | 1979-04-23 | 60 | 0 |
| K790008 | I ESTRIOL | Cambridge Nuclear Corp. | 1979-02-26 | 55 | 0 |
| K790007 | I TESTOTERONE | Cambridge Nuclear Corp. | 1979-02-26 | 55 | 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