Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kvm Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925666 | THERAPACER 3000 | Kvm Technologies, Inc. | 1993-03-09 | 119 | 0 |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | Kvm Technologies, Inc. | 1988-10-12 | 22 | 0 |
| K883989 | KVM ISOTONIC FLUSH SOLUTION | Kvm Technologies, Inc. | 1988-10-12 | 22 | 0 |
| K883990 | KVM ISOTONIC DILUENT | Kvm Technologies, Inc. | 1988-10-12 | 22 | 0 |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | Kvm Technologies, Inc. | 1988-10-12 | 22 | 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