# K991301: Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon Valve, Cadd Administration Set with 1

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Jun 9, 1999 after 54 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933390 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943310: Model 6100 Ambulatory Infusion System, Pharmacia Deltec, Inc. (1995) Summary page 2.
- K933390: Remote Reservoir Adapter (TM) Cassette with Bag, Pharmacia Deltec, Inc. (1994) Summary page 2.
- K954870: Sims Deltec Anti-Siphon Valve, Sims Deltec, Inc. (1995) Summary page 2.

## Recalls of this device
- Dec 9, 2011 · Not classified · Z-0775-2012: Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. EXPANDED: Smiths Medical

## Indications for use
The CADD-Prizm® High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag. The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.

Source page: https://510kreport.com/device/K991301
Methodology: https://510kreport.com/methodology