# K990091: S.P.a.R Sterile Ambulatory Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Faulding Pharmaceutical Co.
- Decided: Apr 4, 1999 after 83 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
Longest line of descent: 1 generation back to K843772 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843772: Cadd-1 5100 Ambulatory Infusion Pump, Deltec Systems, Inc. (1984) Summary page 1.

## Indications for use
The S.P.A.R.™ Sterile Ambulatory Reservoir is intended for use with the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 Ambulatory Infusion Pumps, manufactured and distributed by Sims Deltec Inc., St. Paul, Minnesota. The S.P.A.R.™ Ambulatory Reservoir is intended for use as an accessory to the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps by replacing the Deltec Medication Cassette ™, Model 2050 - 50 mL and 2100 - 100 mL with S.P.A.R. ™ Sterile Ambulatory Reservoir.

Source page: https://510kreport.com/device/K990091
Methodology: https://510kreport.com/methodology