Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KMS — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
67 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872886 | CARBON DIOXIDE | Catachem, Inc. | 1987-08-13 | 22 | 0 |
| K870025 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | American Research Products Co. | 1987-03-13 | 67 | 0 |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Panmed, Inc. | 1980-10-10 | 32 | 0 |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | Diagnostic Solutions, Inc. | 1980-05-30 | 65 | 0 |
| K780506 | CARBON DIOXIDE REAGENTS | Gamma Enterprises, Inc. | 1978-05-03 | 34 | 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