Cleared Traditional

K163357 - OneTouch Via On-Demand Insulin Delivery System

K163357 is an FDA 510(k) clearance for OneTouch Via On-Demand Insulin Delivery..., manufactured by Lifescan Europe, A Division of Cilag GmbH. The device is a Class 2 General Hospital device with product code OPP cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K163357 · Lifescan Europe, A Division of Cilag GmbH · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
189d
Days
Class 2
Risk

K163357 is an FDA 510(k) clearance for the OneTouch Via On-Demand Insulin Delivery System. Classified as Pump, Infusion, Insulin Bolus (product code OPP), Class II - Special Controls.

Submitted by Lifescan Europe, A Division of Cilag GmbH (Zug, CH). The FDA issued a Cleared decision on June 7, 2017 after a review of 189 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163357

510(k) Number K163357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date June 07, 2017
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OPP Device Classification - Class 2, Special Controls

Product Code OPP Pump, Infusion, Insulin Bolus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Lifescan, Inc.
Kirsten Franco

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OPP Pump, Infusion, Insulin Bolus

Devices cleared under the same product code (OPP) and FDA review panel - the closest regulatory comparables to K163357.
CeQur Simplicity™ On-Demand Insulin Delivery System
K252757 · Cequr SA · Apr 2026
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273 · Cequr SA · Nov 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · Cequr SA · Jan 2024
FINESSE PERSONAL INSULIN DELIVERY PATCH
K111924 · Calibra Medical, Inc. · Apr 2012
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
K100947 · Calibra Medical, Inc. · Jun 2010
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
K093065 · Calibra Medical, Inc. · Jan 2010
K163357 · OneTouch Via On-Demand Insulin Delivery System
Download PDF FDA Summary Lifescan Europe, A Di…