# K023892: Millex VV, GV, and HV Syringe Filter Units

- Pathway: 510(k) (Traditional)
- Applicant: Millipore Corp.
- Decided: Jan 17, 2003 after 56 days
- Product code: BSN (Filter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133004: Vented Millex -GV, Cathivex -GV (2014), 0 descendants of its own

## Recalls of this device
- Nov 25, 2009 · Not classified · Z-1044-2010: Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter.

## Indications for use
Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.

Source page: https://510kreport.com/device/K023892
Methodology: https://510kreport.com/methodology