510(k) · Cleared
ClearedAutoprime
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arbor Technologies, Inc. · FPB Filter, Infusion Line
Cleared on Jan 22, 1997 after an 86-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 22, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- FPB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (2)
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 |
|---|---|---|---|
| * | — | 3M Health Care AVI™ Administration Set with an 0.22um filter Named without a submission number | |
| * | — | Block Medical Verifuse® Administration Set with 1.2 um IV-3 Named without a submission number |
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.
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 | — |
What is it indicated for?
All filters are intended to filter intravenous solutions.
Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an |V filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered, a 0.22um air eliminating filter for nonlipid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964283: Autoprime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964283
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026