MiniMed Go App— 510(k) K253512
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K253512 for MiniMed Go App, Substantially Equivalent on 2026-01-08. Applicant: Medtronic Minimed. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code NDC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code NDC
view allMore clearances from Medtronic Minimed
view allAdverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K253512
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K253512.
Data sourced from openFDA. This site is unofficial and independent of the FDA.