510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962159Substantially Equivalent

Sterile Ambulatory Reservoir 60Ml/100ml

Faulding Medical Device Co., Scottsdale AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962159 is the FDA 510(k) clearance record for STERILE AMBULATORY RESERVOIR 60ML/100ML, a class II device, cleared for Faulding Medical Device Co. on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list 6 510(k) clearances for Faulding Medical Device Co., from to . As of , FDA records show no recalls naming K962159.

Clearance record

Decision date
Received
(409 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Faulding Medical Device Co. 8777 E. Via De Ventura,, Scottsdale AZ
510(k) summary
Statement
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