# K982048: MPS Reservoir Bag

- Pathway: 510(k) (Traditional)
- Applicant: Medical Product Specialists
- Decided: Jul 27, 1998 after 47 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- 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) Baxter Drug Bag: named in the summary without a submission number

## Indications for use
The MPS Reservoir Bag is intended for use with Ambulatory PCA or APII pumps for continuous infusion therapy. For use for infusion of I.V. fluids, and drugs. Refer to the directions for use of the infusion pump for compatible indications for use. For use up to 24 hours per CDC guidelines or per hospital protocol. For use with standard luer taper connections. For single patient use.

Source page: https://510kreport.com/device/K982048
Methodology: https://510kreport.com/methodology