Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syncor Intl. Corp. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
146 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945825 | SECURE SAFETY INSERT | Syncor Intl. Corp. | 1995-04-10 | 132 | 0 |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Syncor Intl. Corp. | 1985-09-19 | 146 | 0 |
| K850433 | CESIUM 137 ENDOMETRIAL SOURCE | Syncor Intl. Corp. | 1985-08-21 | 198 | 0 |
| K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 | Syncor Intl. Corp. | 1985-08-21 | 105 | 0 |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Syncor Intl. Corp. | 1985-08-13 | 50 | 0 |
| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | Syncor Intl. Corp. | 1985-06-21 | 101 | 0 |
| K844735 | PTH-RIA | Syncor Intl. Corp. | 1985-04-29 | 146 | 0 |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Syncor Intl. Corp. | 1985-03-26 | 32 | 0 |
| K850163 | IRIDIUM 192 WIRES | Syncor Intl. Corp. | 1985-03-26 | 69 | 0 |
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Syncor Intl. Corp. | 1985-03-26 | 67 | 0 |
| K850434 | CS137 SEALED SOURCES | Syncor Intl. Corp. | 1985-03-26 | 50 | 0 |
| K850207 | PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL | Syncor Intl. Corp. | 1985-03-01 | 42 | 0 |
| K844582 | SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST | Syncor Intl. Corp. | 1985-01-16 | 54 | 0 |
| K844160 | VENTIBOX | Syncor Intl. Corp. | 1984-12-17 | 54 | 0 |
| K844181 | ACTH RIA | Syncor Intl. Corp. | 1984-11-27 | 32 | 0 |
| K842445 | LH RIA | Syncor Intl. Corp. | 1984-09-04 | 75 | 0 |
| K842444 | FSH RIA | Syncor Intl. Corp. | 1984-08-17 | 57 | 0 |
| K842598 | STAR HCG MONOCLONAL ANTIBODY IMMUNO | Syncor Intl. Corp. | 1984-07-26 | 35 | 0 |
| K842167 | TBG RIA | Syncor Intl. Corp. | 1984-07-09 | 39 | 0 |
| K841927 | T3 UPTAKE | Syncor Intl. Corp. | 1984-06-25 | 46 | 0 |
| K841963 | GASTRIN RIA | Syncor Intl. Corp. | 1984-06-25 | 42 | 0 |
| K841854 | BHCG RIA | Syncor Intl. Corp. | 1984-06-22 | 50 | 0 |
| K840127 | CURIETRON | Syncor Intl. Corp. | 1984-03-19 | 68 | 0 |
| K833851 | HCG RIA | Syncor Intl. Corp. | 1984-03-19 | 136 | 0 |
| K833853 | T3 RIA | Syncor Intl. Corp. | 1984-02-04 | 92 | 0 |
| K833849 | ACTH RIA | Syncor Intl. Corp. | 1984-01-30 | 87 | 0 |
| K832796 | STAR HCG MONOCLONAL ANTIBODY IMMUNORAD | Syncor Intl. Corp. | 1984-01-24 | 159 | 0 |
| K833850 | T4 RIA | Syncor Intl. Corp. | 1984-01-18 | 75 | 0 |
| K833852 | FSH RIA | Syncor Intl. Corp. | 1984-01-13 | 70 | 0 |
| K833854 | LH RIA | Syncor Intl. Corp. | 1984-01-13 | 70 | 0 |
| K833910 | TSH RIA | Syncor Intl. Corp. | 1983-11-22 | 8 | 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