510(k) · Cleared
ClearedVented Millex -GV, Cathivex -GV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merck Millipore, Ltd. · BSN Filter, Conduction, Anesthetic
Cleared on Mar 27, 2014 as substantially equivalent to K023892 (Millipore Corp., 2003) after a 183-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Mar 27, 2014
- Review
- 183 days
- Class
- Class II
- Product code
- BSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023892 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023892 Millex VV, GV, and HV Syringe Filter UnitsMillipore Corp. · 2003 · Recalled
- This deviceK133004 Vented Millex -GV, Cathivex -GVMerck Millipore, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023892 | Millex VV, GV, and HV Syringe Filter Units | Millipore Corp. | 2003 | 1 |
| 0 (this device) | K133004 | Vented Millex -GV, Cathivex -GV | Merck Millipore, Ltd. | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023892 | Millex VV, GV, and HV Syringe Filter UnitsSummary page 2…tion Device Trade Name Millex®-GV, 33mm Model Number SLGVM33RS 510(k) Number K023892 Clearance date 1/1 7/2003 Device Class 11 Product Codes… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All BSN devicesBSN Filter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Vented Millex®-GV filter units are syringe filters for sterilization of low volume aqueous solutions for direct patient injection, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.
Cathivex®-V filter units are in-line gravity fed filters for the sterilization of aqueous solutions for administration via the neuraxial route, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133004: Vented Millex -GV, Cathivex -GV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133004
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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