Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocircuits Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
209 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981634 | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRID | Biocircuits Corp. | 1998-10-13 | 158 | 0 |
| K980819 | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRC | Biocircuits Corp. | 1998-04-03 | 31 | 0 |
| K963770 | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS | Biocircuits Corp. | 1996-12-05 | 77 | 0 |
| K961566 | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS | Biocircuits Corp. | 1996-11-18 | 209 | 0 |
| K961792 | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY | Biocircuits Corp. | 1996-08-21 | 104 | 0 |
| K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | Biocircuits Corp. | 1995-11-22 | 160 | 0 |
| K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES | Biocircuits Corp. | 1995-11-20 | 158 | 0 |
| K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE | Biocircuits Corp. | 1995-11-20 | 97 | 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