510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203234Substantially Equivalent

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

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

K203234 is the FDA 510(k) clearance record for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app), a class II device, cleared for Tandem Diabetes Care, Inc. on under FDA product code QFG (Alternate Controller Enabled Insulin Infusion Pump). FDA's definition for product code QFG reads: "An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin...". FDA records list 26 510(k) clearances for Tandem Diabetes Care, Inc., from to . As of , FDA records show 2 recalls naming K203234.

Clearance record

Decision date
Received
(469 days to decision)
Product code
QFG Alternate Controller Enabled Insulin Infusion Pump
Regulation
21 CFR 880.5730
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tandem Diabetes Care, Inc. 11075 Roselle St., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFG

Trailing 12 months
6 clearances under product code QFG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QFG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260