Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIB — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
382 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL S | Immunodiagnostic Systems , Ltd. | 2013-12-24 | 382 | 0 |
| K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON EN | DiaSorin, Inc. | 2013-01-01 | 182 | 0 |
| K062120 | CISBIO RENIN RIA TEST | Cis Bio International | 2007-03-30 | 248 | 0 |
| K061758 | ACTIVE RENIN IRMA | Diagnostic Systems Laboratories, Inc. | 2006-07-28 | 36 | 0 |
| K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VER | Nichols Institute Diagnostics | 2001-09-06 | 146 | 0 |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | Diagnostic Systems Laboratories, Inc. | 1998-05-27 | 22 | 1 |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | Buhlmann Laboratories AG | 1995-10-19 | 35 | 0 |
| K940004 | AI-PHOTODIAGNOSTIC | Pharmarceutical Discovery Corp. | 1995-08-04 | 578 | 0 |
| K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | Nichols Institute Diagnostics | 1993-01-06 | 40 | 0 |
| K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-29 | 80 | 2 |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-10-11 | 76 | 0 |
| K833777 | ANGIOTENSIN CONVERTING ENZYME | Immuno-Diagnostic Laboratories | 1984-01-30 | 95 | 0 |
| K831694 | RENAK | Hoffmann-La Roche, Inc. | 1983-07-19 | 56 | 0 |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | E. R. Squibb & Sons, Inc. | 1982-03-26 | 18 | 0 |
| K800774 | RENCTK | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 | 14 | 0 |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | 1976-12-30 | 14 | 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