Cleared Traditional

K161865 - iSage Rx (iSage Rx Basal Insulin Titration)

K161865 is an FDA 510(k) clearance for iSage Rx (iSage Rx Basal Insulin Titration), manufactured by Isag Rx, Inc.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K161865 · Isag Rx, Inc. · General Hospital
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Mar 2017
Decision
243d
Days
Class 2
Risk

K161865 is an FDA 510(k) clearance for the iSage Rx (iSage Rx Basal Insulin Titration). Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Isag Rx, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 7, 2017 after a review of 243 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - 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 - K161865

510(k) Number K161865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2016
Decision Date March 07, 2017
Days to Decision 243 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 129d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 Peers - NDC Calculator, Drug Dose

All 52
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K161865.
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K150910 · Roche Diabetes Care, Inc. · Jun 2015
K161865 · iSage Rx (iSage Rx Basal Insulin Titration)
Download PDF Isag Rx, Inc.