# K993524: Advantis Asc Infusion Pump and Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Aug 1, 2000 after 288 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792538 (1979). 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)
- K914589: Sabratek 3030 Infusion Pump, Sabratek Corp. (1992) Summary page 1.
- K915522: Flo-Gard (R) 6201, Baxter Healthcare Corp (1992) Summary page 1.
- K792538: Continu-Flo Admin. Set Code 2C/200, Travenol Laboratories, S.A. (1979) Summary page 1.

## Indications for use
The Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application. ALARIS Medical’s policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the Advantis ASC. No such contraindications have been identified.

Source page: https://510kreport.com/device/K993524
Methodology: https://510kreport.com/methodology