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

Interoperable Automated Glycemic Controller, Insulin Suspend

21 CFR 862.1356 / Clinical Chemistry
FDA source (opens on fda.gov)

QJS is the FDA product code for Interoperable Automated Glycemic Controller, Insulin Suspend, a class II device type, regulated under 21 CFR 862.1356. FDA's definition for this code 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 automated glycemic controllers, insulin suspend, are designed to reliably and securely...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QJS
Device name
Interoperable Automated Glycemic Controller, Insulin Suspend
FDA definition
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 automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Regulation
21 CFR 862.1356
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QJS

By decision year
1 clearance under product code QJS with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QJS by decision year
YearClearances
20201

Applicants with the most clearances

Product code QJS
Applicants holding the most 510(k) clearances under product code QJS
ApplicantClearances
Tandem Diabetes Care, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code