Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Venous Health Systems, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131046 | VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CAL | Venous Health Systems, Inc. | 2013-07-18 | 94 | 0 |
| K122609 | VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLE | Venous Health Systems, Inc. | 2012-12-21 | 116 | 0 |
| K103113 | VASCULAIRE COMPRESSION SYSTEM | Venous Health Systems, Inc. | 2011-02-02 | 104 | 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