Control-IQ Technology
FDA 510(k) clearance DEN190034 · decided 2019-12-13
Clearance details
- K-number
- DEN190034
- Device name
- Control-IQ Technology
- Applicant
- Tandem Diabetes Care, Inc.
- Decision
- Unknown
- Date received
- 2019-07-15
- Decision date
- 2019-12-13
- Days to decision
- 151 days
- Clearance type
- Direct
- Product code
- QJI
- Device class
- 2
- Regulation number
- 862.1356
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| Omnipod 6 algorithm (K261461) | Insulet Corporation | 2026-06-29 |
| Control-IQ+ technology (K260429) | Tandem Diabetes Care, Inc. | 2026-04-24 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| SmartGuard technology; Predictive Low Glucose technology (K253585) | Medtronic Minimed, Inc. | 2026-01-14 |
| DBLG2 (K251152) | Diabeloop | 2025-12-19 |
| Omnipod 5 algorithm (K251779) | Insulet Corporation | 2025-12-03 |
| SmartGuard technology; Predictive Low Glucose technology (K251217) | Medtronic Minimed, Inc. | 2025-08-29 |
| Control-IQ+ technology (K250798) | Tandem Diabetes Care, Inc. | 2025-05-21 |
| Control-IQ+ technology (K243823) | Tandem Diabetes Care, Inc. | 2025-02-24 |
| SmartAdjust™ Technology (K241777) | Insulet Corporation | 2024-08-26 |
| SmartAdjust(TM) technology (K232741) | Insulet Corporation | 2024-05-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S029) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S007) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S028) | Tandem Diabetes Care, Inc. | 2019-03-01 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S002) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S003) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S001) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S027) | Tandem Diabetes Care, Inc. | 2018-10-26 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S006) | Tandem Diabetes Care, Inc. | 2018-10-26 |