Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CIL · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922953 | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | 83 | 0 |
| K895880 | PANCREATIC A-AMYLASE EPS | Boehringer Mannheim Corp. | 1989-12-19 | 75 | 0 |
| K833724 | ENZYMATIC CO2 | American Monitor Corp. | 1983-12-29 | 66 | 0 |
| K800111 | CO2 CONTENT | American Monitor Corp. | 1980-02-13 | 28 | 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