Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CHS · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
85 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | Medical Analysis Systems, Inc. | 1993-02-03 | 50 | 0 |
| K911838 | ROCHE REAGENT FOR C02 | Roche Diagnostic Systems, Inc. | 1991-07-19 | 85 | 0 |
| K860660 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | Amresco, Inc. | 1986-03-14 | 18 | 0 |
| K841080 | TECHNICON RA-1000 SYS CO2 | Technicon Instruments Corp. | 1984-05-02 | 50 | 0 |
| K811257 | CORNING 965 CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | 1981-05-27 | 22 | 0 |
| K802376 | KODAK EKTA-CHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | 1980-10-23 | 23 | 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