510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993832Substantially Equivalent

Autodose Infusion System, Model Ad4120, Be4210, S12050,100,200, Ff0005, 10

Tandem Medical, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993832 is the FDA 510(k) clearance record for AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10, a class II device, cleared for Tandem Medical, Inc. on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 2 510(k) clearances for Tandem Medical, Inc., from to . As of , FDA records show no recalls naming K993832.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Tandem Medical, Inc. 15910 Bernardo Center Dr., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code MEB

Trailing 12 months
1 clearance under product code MEB in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260