Cleared Traditional

K162225 - WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

K162225 is an FDA 510(k) clearance for WellDoc BlueStar (WellDoc DiabetesManag..., manufactured by Welldoc, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K162225

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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 45
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K162225.
Sapphire Sets
K171346 · Icu Medical · Aug 2017
WellDoc BlueStar, WellDoc BlueStar Rx
K162532 · Welldoc, Inc. · Jan 2017
Hospira Sapphire Sets
K160492 · Hospira, Inc. · Dec 2016
ivWatch Model 400
K142374 · Ivwatch, LLC · Feb 2015
SMART LABEL, PROPOFOL
K142333 · American I.V. Products, Inc. Dba Aiv, Inc. · Dec 2014
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
K141273 · Welldoc, Inc. · Jul 2014