510(k) · Cleared
Recalled · 2009Millex VV, GV, and HV Syringe Filter Units
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millipore Corp. · BSN Filter, Conduction, Anesthetic
Cleared on Jan 17, 2003 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 17, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- BSN
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023892 Millex VV, GV, and HV Syringe Filter UnitsMillipore Corp. · 2003
- Descendant · cites it directly · 0 of its ownK133004 Vented Millex -GV, Cathivex -GVMerck Millipore, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133004Vented Millex -GV, Cathivex -GVMerck Millipore, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023892 | Millex VV, GV, and HV Syringe Filter Units | Millipore Corp. | 2003 | — |
| +1 | K133004 | Vented Millex -GV, Cathivex -GV | Merck Millipore, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BSN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133004 | Vented Millex -GV, Cathivex -GV | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2009 | Not classified | Z-1044-2010 | Process control | Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133004 (Merck Millipore, Ltd., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BSN devicesBSN Filter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BSN
Too few BSN 510(k)s in any year since 2007 to give a median.
Recalls per year · BSN
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BSN
6in 2025
MAUDE reports naming product code BSN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 88 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023892: Millex VV, GV, and HV Syringe Filter Units.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023892
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026