Cleared Traditional

T:CONNECT DATA MANAGEMENT SYSTEM (K122361) - FDA 510(k) Clearance

Class I General Hospital device.

K122361 · Tandem Diabetes Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.