Cleared Special

K112370 - WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

K112370 is an FDA 510(k) clearance for WELLDOC DIABETES MANAGER SYSTEM AND DIA..., manufactured by Welldoc, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Special 510(k) pathway after a 58-day FDA review.

K112370 · Welldoc, Inc. · General Hospital
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Oct 2011
Decision
58d
Days
Class 2
Risk

K112370 is an FDA 510(k) clearance for the WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Welldoc, Inc. (Baltimore, US). The FDA issued a Cleared decision on October 14, 2011 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Welldoc, Inc. devices

FDA 510(k) Submission Details - K112370

510(k) Number K112370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2011
Decision Date October 14, 2011
Days to Decision 58 days
Submission Type Special
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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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
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