DeviceClearance

Product code MLR— General Hospital

V-PRO maX 2 Low Temperature Sterilization System

Classification name
Sterilizer, Chemical
Device class
Class 2
Regulation
21 CFR 880.6860
Advisory panel
General Hospital
Total cleared
47
First cleared
Most recent

Market context for product code MLR

FDA has cleared 47 devices under product code MLR between 1994 and 2026, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MLR

Adverse events under product code MLR

product code MLR
Malfunction
805
Total
805

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MLR

Data sourced from openFDA. This site is unofficial and independent of the FDA.