Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C-V Monitors Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
63 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K792099 | 50MM WRITER MODEL CVM 9529 | C-V Monitors Corp. | 1979-10-26 | 7 | 0 |
| K790004 | MONITOR SCOPES, MODELS 9502, 9503 | C-V Monitors Corp. | 1979-02-28 | 57 | 0 |
| K781867 | WRITER, GEMINI-3 | C-V Monitors Corp. | 1979-01-05 | 63 | 0 |
| K780572 | DCG PREAMPLIFIER MODULE | C-V Monitors Corp. | 1978-05-09 | 29 | 0 |
| K780571 | BLOOD PRESSURE MODULE | C-V Monitors Corp. | 1978-05-09 | 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