Cleared Traditional

K122361 - T:CONNECT DATA MANAGEMENT SYSTEM

K122361 is an FDA 510(k) clearance for T:CONNECT DATA MANAGEMENT SYSTEM, manufactured by Tandem Diabetes Care, Inc.. The device is a Class 1 General Hospital device with product code OUG cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K122361 · Tandem Diabetes Care, Inc. · General Hospital
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Feb 2013
Decision
203d
Days
Class 1
Risk

K122361 is an FDA 510(k) clearance for the T:CONNECT DATA MANAGEMENT SYSTEM. Classified as Medical Device Data System (product code OUG), Class I - General Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6310 - 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 Tandem Diabetes Care, Inc. devices

FDA 510(k) Submission Details - K122361

510(k) Number K122361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2012
Decision Date February 22, 2013
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

OUG Device Classification - Class 1, General Controls

Product Code OUG Medical Device Data System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6310
Definition A Medical Device Data System (mdds) Is A Device That Is Intended To Provide One Or More Of The Following Uses, Without Controlling Or Altering The Functions Or Parameters Of Any Connected Medical Devices: (i) The Electronic Transfer Of Medical Device Data; (ii) The Electronic Storage Of Medical Device Data; (iii) The Electronic Conversion Of Medical Device Data From One Format To Another Format In Accordance With A Preset Specification; Or (iv) The Electronic Display Of Medical Device Data. (2) An Mdds May Include Software, Electronic Or Electrical Hardware Such As A Physical Communications Medium (including Wireless Hardware), Modems, Interfaces, And A Communications Protocol. This Identification Does Not Include Devices Intended To Be Used In Connection With Active Patient Monitoring.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.