Cleared Traditional

K163357 - OneTouch Via On-Demand Insulin Delivery System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163357 · Lifescan Europe, A Division of Cilag GmbH · General Hospital
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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.

View all Lifescan Europe, A Division of Cilag GmbH devices

Submission Details

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
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 128d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.