510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193483Substantially Equivalent

Basal-IQ Technology

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

K193483 is the FDA 510(k) clearance record for Basal-IQ Technology, a class II device, cleared for Tandem Diabetes Care, Inc. on under FDA product code QJS (Interoperable Automated Glycemic Controller, Insulin Suspend). FDA's definition for product code QJS reads: "An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable...". FDA records list 26 510(k) clearances for Tandem Diabetes Care, Inc., from to . As of , FDA records show one recall naming K193483.

Clearance record

Decision date
Received
(73 days to decision)
Product code
QJS Interoperable Automated Glycemic Controller, Insulin Suspend
Regulation
21 CFR 862.1356
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 QJS

Trailing 12 months

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

FDA records show no clearances under product code QJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QJS, 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