510(k) · Cleared
Recalled · Class I · 2025Basal-IQ Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care, Inc. · QJS Interoperable Automated Glycemic Controller, Insulin Suspend
Cleared on Feb 28, 2020 as substantially equivalent to DEN190034 (Tandem Diabetes Care, Inc., 2019) and 1 other predicate after a 73-day review. Its family tree reaches back 9 generations to 2001. 1 of the 19 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Feb 28, 2020
- Review
- 73 days
- Class
- Class II
- Product code
- QJS
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 9 generations to K010362 (2001). 18 ancestors in all. No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 5 generations between
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 1 generation backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- This deviceK193483 Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 8 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 7 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 6 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 5 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 4 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 1 generation backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- This deviceK193483 Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −8 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −7 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −6 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −5 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −4 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −3 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −2 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −1 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| 0 (this device) | K193483 | Basal-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN190034 | Control-IQ TechnologySummary page 4…ithm QJS Calculator NDC IX. Predicate Device Algorithm DEN190034, Control-IQ technology Calculator K192841, InPen Dose Calculator X. Description… | 2019 |
| * | K190487 | InPen Dose Calculator Cleared while this submission was under review Summary page 7…Calculator Predicate Device Subject Device (K190487, InPen Dose Calculator) (K193483) Indications The InPen dose calculator, a The bo… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2025 | Class I | Z-2343-2025 | Nonconforming Material/Component | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate DEN190034.
How does its category compare?
All QJS devicesQJS Interoperable Automated Glycemic Controller, Insulin Suspend: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QJS
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QJS
Too few QJS 510(k)s in any year since 2007 to give a median.
Recalls per year · QJS
No recall names QJS since 2007.
Adverse event reports per year · QJS
1in 2022
MAUDE reports naming product code QJS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Basal-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values.
Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater.
Basal-IQ technology is intended for single patient use and requires a prescription.
Basal-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.
The bolus calculator is indicated for the management of diabetes by people with diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193483: Basal-IQ Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193483
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026