Cleared Traditional

K162225 - WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (FDA 510(k) Clearance)

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

K162225 · Welldoc, Inc. · General Hospital
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Nov 2016
Decision
106d
Days
Class 2
Risk

K162225 is an FDA 510(k) clearance for the WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on November 22, 2016 after a review of 106 days - within the typical 510(k) review window.

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 Welldoc, Inc. devices

Submission Details

510(k) Number K162225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date November 22, 2016
Days to Decision 106 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
22d faster than avg
Panel avg: 128d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.