Cleared Traditional

K161865 - iSage Rx (iSage Rx Basal Insulin Titration) (FDA 510(k) Clearance)

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

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.

View all Isag Rx, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 128d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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