K240158 is an FDA 510(k) clearance for the Modular Medical MODD1 Insulin Delivery System. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Modular Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 2024, 229 days after receiving the submission on January 19, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K240158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2024 |
| Decision Date | September 04, 2024 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LZG - Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |