Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vasomedical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
204 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER | Vasomedical, Inc. | 2011-06-28 | 62 | 0 |
| K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOO | Vasomedical, Inc. | 2011-06-24 | 65 | 0 |
| K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RE | Vasomedical, Inc. | 2010-04-02 | 204 | 0 |
| K083820 | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MO | Vasomedical, Inc. | 2009-04-01 | 100 | 0 |
| K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | Vasomedical, Inc. | 2004-03-01 | 104 | 0 |
| K020857 | EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANC | Vasomedical, Inc. | 2002-06-14 | 88 | 0 |
| K003469 | EECP THERAPY SYSTEM, MODEL TS3 | Vasomedical, Inc. | 2000-12-06 | 28 | 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