510(k) · Cleared
Recalled · 2002Auto Syringe Micro Vol Ext Set W/Air Vent Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Travenol Laboratories, S.A. · FPB Filter, Infusion Line
Cleared on Apr 7, 1986 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 7, 1986
- Review
- 39 days
- Class
- Class II
- Product code
- FPB
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK860746 Auto Syringe Micro Vol Ext Set W/Air Vent FilterTravenol Laboratories, S.A. · 1986
- Descendant · cites it directly · 0 of its ownK113227 Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterBaxter Healthcare Corp · 2011
Most influential descendants
Showing 1 of 1 · See all- K113227Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterBaxter Healthcare Corp · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860746 | Auto Syringe Micro Vol Ext Set W/Air Vent Filter | Travenol Laboratories, S.A. | 1986 | — |
| +1 | K113227 | Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter | Baxter Healthcare Corp | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K113227 | Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2002 | Not classified | Z-0520-03 | Other | The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter. |
| Oct 17, 2002 | Not classified | Z-0521-03 | Other | The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113227 (Baxter Healthcare Corp, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FPB devicesFPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K860746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860746: Auto Syringe Micro Vol Ext Set W/Air Vent Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860746
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026