Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JKD — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
124 daysmedian FDA review time
298 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951848 | AIA-PACK CPR ASSAY | Tosoh Medics, Inc. | 1996-02-13 | 298 | 0 |
| K943767 | IMMULITE C-PEPTIDE | Diagnostic Products Corp. | 1995-03-23 | 233 | 0 |
| K896420 | DSL C-PEPTIDE RIA (DSL #7000) | Diagnostic Systems Laboratories, Inc. | 1990-05-24 | 197 | 0 |
| K854066 | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | Diagnostic Products Corp. | 1985-11-12 | 39 | 0 |
| K842267 | C-PEP-RIA-100 | Institut National Des Radioelements | 1984-09-06 | 90 | 0 |
| K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-04-13 | 196 | 0 |
| K820666 | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | Immuno Nuclear Corp. | 1982-07-13 | 124 | 0 |
| K812689 | RIA QUANT C-PEPTIDE KIT | Mallinckrodt Critical Care | 1981-10-06 | 14 | 0 |
| K812288 | HUMAN C-PEPTIDE REAGENTS | Immunex Radiochemical Diagnostics | 1981-08-31 | 18 | 0 |
| K810718 | C-PEPTICE REAGENTS | Calbiochem-Behring Corp. | 1981-03-31 | 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