Cleared Traditional

K171450 - Glooko Mobile Insulin Dosing System

K171450 is an FDA 510(k) clearance for Glooko Mobile Insulin Dosing System, manufactured by Glooko, Inc.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K171450 · Glooko, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
261d
Days
Class 2
Risk

K171450 is an FDA 510(k) clearance for the Glooko Mobile Insulin Dosing System. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Glooko, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 2, 2018 after a review of 261 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 Glooko, Inc. devices

FDA 510(k) Submission Details - K171450

510(k) Number K171450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2017
Decision Date February 02, 2018
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
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 42
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