InPen System App (MMT-8060 (iOS), MMT-8061 (Android))— 510(k) K242775
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K242775 for InPen System App (MMT-8060 (iOS), MMT-8061 (Android)), Substantially Equivalent on 2024-11-12. 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
- Northridge, 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 K242775
K-number listed on FDA's recall record- Z-0958-2026 — InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Z-2496-2025 — InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
- Z-1650-2025 — InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242775.
Data sourced from openFDA. This site is unofficial and independent of the FDA.