510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143189Substantially Equivalent

t:flex Insulin Delivery System

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

K143189 is the FDA 510(k) clearance record for t:flex Insulin Delivery System, a class II device, cleared for Tandem Diabetes Care, Inc. on under FDA product code LZG (Pump, Infusion, Insulin). FDA records list 26 510(k) clearances for Tandem Diabetes Care, Inc., from to . As of , FDA records show no recalls naming K143189.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LZG Pump, Infusion, Insulin
Regulation
21 CFR 880.5725
Device class
Class II
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 LZG

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