Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio Kinetics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
29 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823215 | CKG 8800 | Cardio Kinetics, Inc. | 1982-11-24 | 27 | 0 |
| K822020 | CKG 8000 | Cardio Kinetics, Inc. | 1982-08-06 | 28 | 0 |
| K801485 | SERIES 602 CKG RECORDER (MODIFIED) | Cardio Kinetics, Inc. | 1980-07-08 | 14 | 0 |
| K800851 | SERIES 602 CKGTM RECORDER | Cardio Kinetics, Inc. | 1980-04-24 | 9 | 0 |
| K792051 | CKG CARDIOKYMOGRAPH | Cardio Kinetics, Inc. | 1979-11-13 | 29 | 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