510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K141758Substantially Equivalent

T:slim Insulin Delivery System

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

K141758 is the FDA 510(k) clearance record for T:SLIM 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 K141758.

Clearance record

Decision date
Received
(123 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. 1835 Market St., 29th Floor, Philedelphia PA
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