Tandem Diabetes Care, Inc.: FDA clearances and approvals
Tandem Diabetes Care, Inc. has 24 FDA 510(k) clearances (first 2011, latest 2026), plus 2 PMA and 2 De Novo decisions, across 8 product codes in 2 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 74 days, against 192 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named Tandem Diabetes Care, Inc. It is the industry lead sponsor of 16 device clinical trials on ClinicalTrials.gov. It files with the SEC as TANDEM DIABETES CARE INC (TNDM).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 203 |
| 2014 | 2 | 122 |
| 2015 | 1 | 65 |
| 2016 | 3 | 142 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 73 |
| 2021 | 0 | — |
| 2022 | 1 | 469 |
| 2023 | 4 | 87 |
| 2024 | 2 | 73 |
| 2025 | 5 | 68 |
| 2026 | 1 | 73 |
Review time against the same product codes
Since 2017, Tandem Diabetes Care, Inc.'s cleared 510(k)s took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 10 | 9 |
| LZG | Pump, Infusion, Insulin | 7 | 7 |
| QJI | Interoperable Automated Glycemic Controller | 6 | 5 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| OUG | Medical Device Data System | 1 | 1 |
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 1 | 0 |
| OZO | Automated Insulin Dosing , Threshold Suspend | 1 | 0 |
| QJS | Interoperable Automated Glycemic Controller, Insulin Suspend | 1 | 1 |
Review panels
- Clinical Chemistry (26)
- General Hospital (2)
Most recent Tandem Diabetes Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260429 | Control-IQ+ technology | QJI | 2026-04-24 | 73 |
| K253074 | Tandem Mobi insulin pump with interoperable technology | QFG | 2025-11-06 | 44 |
| K250792 | t:slim X2 insulin pump with interoperable technology | QFG | 2025-09-24 | 194 |
| K251854 | SteadiSet infusion set | FPA | 2025-08-06 | 50 |
| K250798 | Control-IQ+ technology | QJI | 2025-05-21 | 68 |
| K243823 | Control-IQ+ technology | QJI | 2025-02-24 | 74 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | QFG | 2024-07-26 | 98 |
| K240309 | Tandem Mobi insulin pump with interoperable technology | QFG | 2024-03-21 | 48 |
| K232382 | Control-IQ Technology | QJI | 2023-11-03 | 87 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | 2023-11-03 | 87 |
14 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190034 | De Novo | Interoperable Automated Glycemic Controller | 2019-12-13 |
| DEN180058 | De Novo | Alternate Controller Enabled Insulin Infusion Pump | 2019-02-14 |
| P180008 | PMA | t:slim X2 Insulin Pump with Basal-IQ Technology | 2018-06-21 |
| P140015 | PMA | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | 2015-09-08 |
Recalls
13 product recalls in 11 recall events; 10 initiated in the last five years. Most recent: 2026-01-30.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Tandem Diabetes Care, Inc. is the industry lead sponsor of 16 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07211126: The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France (Recruiting, started 2026-03-03)
- NCT07325461: Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes (Recruiting, started 2026-02-18)
- NCT06834568: Tandem Freedom - Feasibility Trial 2 (Completed, started 2025-03-24)
- NCT06717451: PS230005 Control-IQ 1.5 Post-Approval Study (Active not recruiting, started 2025-01-30)
- NCT06428591: Tandem Freedom Feasibility Study 1 (Completed, started 2024-05-29)
SEC filings
TANDEM DIABETES CARE INC (TNDM): EDGAR filings, CIK 1438133. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Tandem Diabetes Care, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZG)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via OYC)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZG)
Frequently asked questions
How many FDA 510(k) clearances does Tandem Diabetes Care, Inc. have?
Tandem Diabetes Care, Inc. has 24 FDA 510(k) clearances (first 2011, latest 2026), plus 2 PMA and 2 De Novo decisions, across 8 product codes in 2 review panels.
How long does FDA take to clear Tandem Diabetes Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tandem Diabetes Care, Inc.'s cleared 510(k)s is 88 days. Since 2017: 74 days, versus 192 days for all cleared 510(k)s in the same product codes.
What devices does Tandem Diabetes Care, Inc. make?
Its most frequent FDA product codes are QFG (Alternate Controller Enabled Insulin Infusion Pump, 10); LZG (Pump, Infusion, Insulin, 7); QJI (Interoperable Automated Glycemic Controller, 6).
Has Tandem Diabetes Care, Inc. had device recalls?
openFDA lists 13 product recalls in 11 recall events by a recalling firm whose name matches Tandem Diabetes Care, Inc; the most recent began 2026-01-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Tandem Diabetes Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QFG, Tandem Diabetes Care, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.