# K964283: Autoprime

- Pathway: 510(k) (Traditional)
- Applicant: Arbor Technologies, Inc.
- Decided: Jan 22, 1997 after 86 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Health Care AVI™ Administration Set with an 0.22um filter: named in the summary without a submission number
- (no number) Block Medical Verifuse® Administration Set with 1.2 um IV-3: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K964283
Methodology: https://510kreport.com/methodology