Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vasamedics, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
192 daysmedian FDA review time
336 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962700 | VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VEN | Vasamedics, LLC | 1997-04-09 | 271 | 0 |
| K961368 | TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT | Vasamedics, LLC | 1996-10-11 | 185 | 0 |
| K951832 | LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, S | Vasamedics, LLC | 1996-03-21 | 336 | 0 |
| K951486 | MODEL PV2000 VASCULAR MICROLABORATORY | Vasamedics, LLC | 1995-06-29 | 91 | 0 |
| K912446 | MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 | Vasamedics, LLC | 1991-12-12 | 192 | 0 |
| K911763 | LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) | Vasamedics, LLC | 1991-08-13 | 116 | 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