510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041152Substantially Equivalent

Thinset 1.8 Ml Reservoir, Model 326A; Thinset 3.0 Ml Reservoir, Model 332A

Applied Diabetes Research, Inc., Dana Point CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041152 is the FDA 510(k) clearance record for THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A, a class II device, cleared for Applied Diabetes Research, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list one 510(k) clearance for Applied Diabetes Research, Inc. As of , FDA records show no recalls naming K041152.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Applied Diabetes Research, Inc. P.O. Box 3900, Dana Point CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRN

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