# K981792: Solution Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 17, 1998 after 88 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832284 (1983). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832284: Solution Admin. Set 2C9096 W/10 PVC, Travenol Laboratories, S.A. (1983) Summary page 2.
- (no number) Solution Administration Sets with 0.22 Micron Filter: named in the summary without a submission number

## Most influential descendants
- K120685: Zyno Medical Administration Set (2012), 12 descendants of its own
- K151151: U & U Intravascular Administration Set (2015), 5 descendants of its own
- K232316: DEKA Infusion System, DEKA Administration Set (2024), 1 descendant of its own
- K230343: ProSeal™ Closed System Administration Set (2023), 1 descendant of its own
- K173361: IV Administration Set (2018), 1 descendant of its own

## Recalls of this device
- Feb 16, 2007 · Not classified · Z-0619-2007: Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
- Feb 16, 2007 · Not classified · Z-0618-2007: Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
- Feb 16, 2007 · Not classified · Z-0620-2007: Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
- Apr 28, 2004 · Not classified · Z-0193-05: Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
- Jul 16, 2003 · Not classified · Z-1158-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

## Indications for use
The solution adminstration set will be used to administer fluids to a patient’s vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague1rM volumetric infusion pumps.

Source page: https://510kreport.com/device/K981792
Methodology: https://510kreport.com/methodology