# K962159: Sterile Ambulatory Reservoir 60ML/100ML

- Pathway: 510(k) (Traditional)
- Applicant: Faulding Medical Device Co.
- Decided: Jul 18, 1997 after 409 days
- Product code: MRZ (Accessories, 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
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The S.P.A.R.™ Sterile Ambulatory Reservoir is intended for use with the Pharmacia Deltec CADD® Model 5800 Ambulatory Infusion Pump, manufactured and distributed by Sims Deltec Inc. St. Paul, Minnesota. The S.P.A.R.™ Medication Reservoir is intended for use as an accessory to the Pharmacia Deltic CADD® infusion pump by replacing the Deltic Medication Cassette™, Model 2050 - 50 mL and 2100 - 100 mL with the S.P.A.R. Reservoir.

Source page: https://510kreport.com/device/K962159
Methodology: https://510kreport.com/methodology