510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K990091Substantially Equivalent

S.p.a.r Sterile Ambulatory Reservoir

Faulding Pharmaceutical Co., Cranford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990091 is the FDA 510(k) clearance record for S.P.A.R STERILE AMBULATORY RESERVOIR, a class II device, cleared for Faulding Pharmaceutical Co. on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list one 510(k) clearance for Faulding Pharmaceutical Co. As of , FDA records show no recalls naming K990091.

Clearance record

Decision date
Received
(83 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Faulding Pharmaceutical Co. 11 Commerce Dr., Cranford NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MRZ

Trailing 12 months

FDA records hold no clearances under product code MRZ in the trailing twelve months.

FDA records show no clearances under product code MRZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260