T: Slim X2 Insulin Pump With Control-IQ
t:slim X2 Insulin Pump with Control-IQ, 7.x, Reconditioned
1manufacturer
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Tandem Diabetes Care, Inc., United States |
|---|---|
| FDA product code | QJI |
| Device type | Interoperable Automated Glycemic Controller |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1356 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-12-23 |
| Record revised | 2023-05-04 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1005012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| twiist | Sequel MED Tech, LLC | 8 |
| iLet Bionic Pancreas | Beta Bionics, Inc. | 6 |
| Tandem t:slim Autosoft 30 Kit | Tandem Diabetes Care, Inc. | 4 |
| Tandem t:slim Autosoft XC Kit | Tandem Diabetes Care, Inc. | 2 |
| iLet Starter Kit – Inset 23″ | Beta Bionics, Inc. | 1 |
| iLet Starter Kit | Beta Bionics, Inc. | 1 |
| iLet Starter Kit – Contact Detach | Beta Bionics, Inc. | 1 |
| Tandem t:slimTruSteel Kit | Tandem Diabetes Care, Inc. | 1 |
| iLet Starter Kit – Inset 32″ | Beta Bionics, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260429 | 2026-04-24 |
| K250798 | 2025-05-21 |
| K243823 | 2025-02-24 |
| K232382 | 2023-11-03 |
| K200467 | 2020-06-16 |
| DEN190034 | 2019-12-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.