510(k) Report

FDA applicant

Tandem Diabetes Care, Inc.

San Diego, CA28 decisions2011–202612 recalls

FDA records 28 decisions for Tandem Diabetes Care, Inc. (San Diego, CA) from 2011 to 2026: 24 510(k) clearances, 2 De Novo grants and 2 original PMA approvals. Most are in product codes QFG (Alternate Controller Enabled Insulin Infusion…) and LZG (Pump, Infusion, Insulin). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 24 of them its own earlier devices. 12 recalls are linked to its devices, 6 Class I.

FDA’s records also spell it “Tandem Diabetes Care”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Tandem Diabetes Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2025

2011: 12013: 12014: 22015: 22016: 32018: 12019: 22020: 32022: 12023: 42024: 22025: 52026 (partial year): 1
2011high 5 (2025) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2026

2014: 1, 1 Class I2018: 12024: 1, 1 Class I2025: 6, 4 Class I2026 (partial year): 3
2011high 6 (2025) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Tandem Diabetes Care, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tandem Diabetes Care, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QFGAlternate Controller Enabled Insulin Infusion Pump10decisions
  • LZGPump, Infusion, Insulin7decisions
  • QJIInteroperable Automated Glycemic Controller6decisions
  • OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1decision
  • QJSInteroperable Automated Glycemic Controller, Insulin Suspend1decision
  • FPASet, Administration, Intravascular1decision

Also: OUG (1), OZO (1).

How long do its 510(k) reviews take?

Since 2016, its 15 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 8 of its 15 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 24 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200467Control-IQ TechnologyTandem Diabetes Care, Inc. · 20204cite it
  • DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 20193cite it
  • K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 20143cite it
  • K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 20232cite it
  • DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc. · 20192cite it
  • K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 20162cite it

What has FDA decided for it lately?

  • K260429Control-IQ+ technologyTandem Diabetes Care, Inc. · 2026
  • K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 20251 recall
  • K250792t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 20251 recall
  • K251854SteadiSet infusion setTandem Diabetes Care · 2025
  • K250798Control-IQ+ technologyTandem Diabetes Care, Inc. · 20251 recall
  • K243823Control-IQ+ technologyTandem Diabetes Care, Inc. · 20251 recall
  • K241078Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc. · 20242 Class I recalls
  • K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 20241 Class I recall

All 27 as Tandem Diabetes Care, Inc. →The one decision as Tandem Diabetes Care →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K240309Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656…Sep 23, 2026
  • K201214Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application…Jul 16, 2026Class II
  • K232380Tandem pumps are battery-operated infusion pumps capable of both basal and bolus…Jan 30, 2026Class II
  • K233044Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated…Oct 6, 2025Class I
  • K201214t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF…Aug 5, 2025Class II
  • K193483Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911…Jul 21, 2025Class I

Other applicant names beginning “Tandem”

FDA records each applicant name separately; these may or may not be the same firm.

Tandem Medical, Inc. 2Tandem Scanning Corp. 1