510(k) · Cleared
ClearedNon-Dehp Micro-Volume Extension Set with 0.22 Micron Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPB Filter, Infusion Line
Cleared on Dec 8, 2011 as substantially equivalent to K860746 (Travenol Laboratories, S.A., 1986) after a 37-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Dec 8, 2011
- Review
- 37 days
- Class
- Class II
- Product code
- FPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860746 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK860746 Auto Syringe Micro Vol Ext Set W/Air Vent FilterTravenol Laboratories, S.A. · 1986 · Recalled
- This deviceK113227 Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterBaxter Healthcare Corp · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860746 | Auto Syringe Micro Vol Ext Set W/Air Vent Filter | Travenol Laboratories, S.A. | 1986 | 2 |
| 0 (this device) | K113227 | Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter | Baxter Healthcare Corp | 2011 | — |
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 FPB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPB device
- #1 K261403 Lipipor NLF1A Infusion Filter, Lipipor NLF2A &…score 11.9 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K860746 | Auto Syringe Micro Vol Ext Set W/Air Vent FilterSummary page 1…Clearance ______ I_ 510(k) Date Auto Syringe MICRO-VOLUME Baxter K860746 April 7, 1986 Extension Set with Air Venting Filter Healtcr… | 1986 |
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 FPB devicesFPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FPB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPB
Too few FPB 510(k)s in any year since 2007 to give a median.
Recalls per year · FPB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPB
33in 2025
MAUDE reports naming product code FPB, 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 | 14 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 1 | — | 1 | 20 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 160 |
| 2022 | 0 | — | 0 | 36 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The I.V. extension set with a 0.22 micron air venting filter is indicated for the
administration of fluid to a patient's vascular system and for the removal of air and
particulate matter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113227: Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113227
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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