510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163357Substantially Equivalent

OneTouch Via On-Demand Insulin Delivery System

Lifescan Europe, A Division of Cilag GmbH, Zug, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163357 is the FDA 510(k) clearance record for OneTouch Via On-Demand Insulin Delivery System, a class II device, cleared for Lifescan Europe, A Division of Cilag GmbH on under FDA product code OPP (Pump, Infusion, Insulin Bolus). FDA's definition for product code OPP reads: "The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus". FDA records list one 510(k) clearance for Lifescan Europe, A Division of Cilag GmbH. As of , FDA records show no recalls naming K163357.

Clearance record

Decision date
Received
(189 days to decision)
Product code
OPP Pump, Infusion, Insulin Bolus
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Lifescan Europe, A Division of Cilag GmbH Gubelstrasse 34, Zug, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OPP

Trailing 12 months
1 clearance under product code OPP 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 OPP, 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