FDA product code QJI: Interoperable Automated Glycemic Controller
QJI is the FDA product code for interoperable automated glycemic controller. It is a Class II device, regulated under 21 CFR 862.1356 and reviewed by the Clinical Chemistry panel. FDA has cleared 23 510(k) submissions under QJI, 22 in the last five years, from 11 different applicants. The average 510(k) review took 167 days (median 87); 124 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Classification
| Field | Value |
|---|---|
| Device name | Interoperable Automated Glycemic Controller |
| Device class | Class II |
| Regulation | 21 CFR 862.1356 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QJI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 111 |
| 2022 | 2 | 294 |
| 2023 | 4 | 332 |
| 2024 | 4 | 171 |
| 2025 | 5 | 139 |
| 2026 | 7 | 61 |
Compare with all 510(k) review times · Search every QJI clearance
Top QJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Insulet Corporation | 6 | 2026-06-29 |
| Tandem Diabetes Care, Inc. | 5 | 2026-04-24 |
| Beta Bionics, Inc. | 3 | 2026-09-11 |
| Medtronic Minimed, Inc. | 2 | 2026-01-14 |
| CamDiab | 1 | 2026-09-16 |
6 more applicants have QJI clearances. See the full list in Caduvo.
Most recent QJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261896 | CamDiab | iOS CamAPS FX | 2026-09-16 | 100 |
| K262763 | Beta Bionics, Inc. | iLet Dosing Decision Software | 2026-09-11 | 38 |
| K261962 | Medtronic MiniMed | SmartGuard Technology; Predictive Low Glucose Technology | 2026-07-09 | 28 |
| K261461 | Insulet Corporation | Omnipod 6 algorithm | 2026-06-29 | 56 |
| K260429 | Tandem Diabetes Care, Inc. | Control-IQ+ technology | 2026-04-24 | 73 |
Recalls for QJI devices
openFDA lists no recalls for product code QJI.
Frequently asked questions
What is FDA product code QJI?
QJI is the FDA product code for interoperable automated glycemic controller. It is a Class II device, regulated under 21 CFR 862.1356 and reviewed by the Clinical Chemistry panel.
What device class is QJI?
Class II, regulation 21 CFR 862.1356. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJI?
Across 23 cleared submissions the average was 167 days from receipt to decision (median 87).
Which companies have the most QJI clearances?
Insulet Corporation (6); Tandem Diabetes Care, Inc. (5); Beta Bionics, Inc. (3); Medtronic Minimed, Inc. (2); CamDiab (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QJI
- Run a recall and safety report across every QJI manufacturer
- Watch product code QJI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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