510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122361Substantially Equivalent

T:connect Data Management System

Tandem Diabetes Care, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122361 is the FDA 510(k) clearance record for T:CONNECT DATA MANAGEMENT SYSTEM, a class I device, cleared for Tandem Diabetes Care, Inc. on under FDA product code OUG (Medical Device Data System). FDA's definition for product code OUG reads: "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...". FDA records list 26 510(k) clearances for Tandem Diabetes Care, Inc., from to . As of , FDA records show no recalls naming K122361.

Clearance record

Decision date
Received
(203 days to decision)
Product code
OUG Medical Device Data System
Regulation
21 CFR 880.6310
Device class
Class I
Review panel
General Hospital
Applicant
Tandem Diabetes Care, Inc. 11045 Roselle St., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUG

Trailing 12 months

FDA records hold no clearances under product code OUG in the trailing twelve months.

FDA records show no clearances under product code OUG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260