K203689 is an FDA 510(k) clearance for the Tidepool Loop. This device is classified as a Interoperable Automated Glycemic Controller (Class II - Special Controls, product code QJI).
Submitted by Tidepool Project (Palo Alto, US). The FDA issued a Cleared decision on January 23, 2023, 767 days after receiving the submission on December 17, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1356. 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..
| 510(k) Number | K203689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2020 |
| Decision Date | January 23, 2023 |
| Days to Decision | 767 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QJI - Interoperable Automated Glycemic Controller |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1356 |
| 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. |