InPen System— 510(k) K192841

Name: FDA 510(k) clearance K192841
Creator: U.S. Food and Drug Administration
Published: 2020-02-10

Substantially Equivalent

Companion Medical, Inc.

FDA 510(k) clearance K192841 for InPen System, Substantially Equivalent on 2020-02-10. 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: 2019-10-03
Decision date: 2020-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NDC

view all

K254102 — Glucommander2026-05-27
K260910 — EndoTool IV Cloud 1.02026-05-01
K253512 — MiniMed Go App2026-01-08
K253281 — UpDoc2025-12-23
K252104 — T1D12025-08-20

More clearances from Companion Medical, Inc.

view all

K201337 — InPen System2020-06-18
K190487 — InPen Dose Calculator2020-02-18
K181327 — InPen Dose Calculator2018-07-06
K160629 — InPen2016-07-26

Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K192841

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, MMT105ELPKNAClass II·Ongoing·Medtronic MiniMed, Inc.·20250304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192841.

Data sourced from openFDA. This site is unofficial and independent of the FDA.