InPen System— 510(k) K201337
Substantially EquivalentCompanion Medical, Inc.
FDA 510(k) clearance K201337 for InPen System, Substantially Equivalent on 2020-06-18. Applicant: Companion Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Companion Medical, Inc.
- 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
- Special
- Location
- San Diego, CA, US
Recent devices under product code NDC
view allMore clearances from Companion Medical, Inc.
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 K201337
K-number listed on FDA's recall record- Z-1650-2025 — InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
- Z-0741-2023 — InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201337.
Data sourced from openFDA. This site is unofficial and independent of the FDA.