Cleared Special

K120314 - WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K120314 · Welldoc, Inc. · General Hospital
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Feb 2012
Decision
23d
Days
Class 2
Risk

K120314 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 February 24, 2012 after a review of 23 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

Submission Details

510(k) Number K120314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2012
Decision Date February 24, 2012
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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.