510(k) K220394
- Device
- SmartAdjust(TM) Technology
- Applicant
- Insulet Corporation
- 510(k) number
- K220394
- Product code
- QJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-19
- Date received
- 2022-02-11
- Regulation
- 862.1356
- Classification name
- Interoperable Automated Glycemic Controller
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alexander Hamad
- Address
- 100 Nagog Park Acton MA US 01720 01720
FDA Registration Numbers#
- 3015192982
- 3019004087
- 3016540876
- 3013756811
- 1220477
- 3016798778
- 2246552
- 2032227
- 3008824097
- 3007981285
- 1220973
- 3014585508
- 3026266833
Source Documents#
Other 510(k) Records For Product Code QJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026-04-24 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026-02-03 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2026-01-14 |
| K251152 | DBLG2 | Diabeloop | 2025-12-19 |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025-12-03 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025-08-29 |
| K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-05-21 |
| K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-02-24 |
| K241777 | SmartAdjust™ Technology | Insulet Corporation | 2024-08-26 |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | 2024-05-29 |
| K232603 | CamAPS FX | Camdiab , Ltd. | 2024-05-23 |
| K234055 | DEKA Loop | Deka Research and Development | 2024-03-13 |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023-11-03 |
| K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-09-22 |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-05-19 |
Legacy Summary#
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FDA Review#
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