FDA Cleared
Existing Device (Modification)
Pathway: 510K
V-Pro maX 2 Low Temperature Sterilization System
Applicant:
STERIS
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
MLR
Review Panel:
General Hospital
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-09-29
Decision Date:
2026-10-29
Total Review Duration:
30 calendar days (30 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Matthew Dobie
Role: SUBMITTER_CONTACT
Becky Aldhizer
Role: US_AGENT
📞 440-3927490
✉️ becky_aldhizer@steris.com
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