# K920736: Ivex-HP96 Extended Life Filter Set

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 23, 1993 after 429 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 9 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1389-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Sep 29, 2005 · Not classified · Z-0133-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0134-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0135-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- May 6, 2005 · Not classified · Z-0195-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Jun 9, 2003 · Not classified · Z-0956-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0955-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0958-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0957-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

Source page: https://510kreport.com/device/K920736
Methodology: https://510kreport.com/methodology