Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cis Radiopharmaceuticals, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
130 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K791860 | FERRITIN RIA KIT | Cis Radiopharmaceuticals, Inc. | 1979-12-06 | 78 | 0 |
| K792063 | FOLLICLE STIMULATING HORMONE (FSH) KIT | Cis Radiopharmaceuticals, Inc. | 1979-11-20 | 36 | 0 |
| K791202 | RIA KIT FOR TRYPSIN | Cis Radiopharmaceuticals, Inc. | 1979-11-05 | 130 | 1 |
| K792000 | LUTEINIZING HORMONE (LH) RIA | Cis Radiopharmaceuticals, Inc. | 1979-10-30 | 25 | 0 |
| K791051 | PROGESTERONE RADIOIMMUNOASSAY KIT | Cis Radiopharmaceuticals, Inc. | 1979-07-24 | 48 | 0 |
| K790003 | RIA KIT, PROLACTIN | Cis Radiopharmaceuticals, Inc. | 1979-03-12 | 69 | 0 |
| K780982 | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT | Cis Radiopharmaceuticals, Inc. | 1978-06-22 | 8 | 0 |
| K771878 | IRIDIUM 192 WIRES & PINS | Cis Radiopharmaceuticals, Inc. | 1977-10-27 | 23 | 0 |
| K760251 | SET, ORAL ADMINISTRATION | Cis Radiopharmaceuticals, Inc. | 1976-09-15 | 58 | 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