ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)— 510(k) K132547

Name: FDA 510(k) clearance K132547
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Substantially Equivalent

Monarch Medical Technologies

FDA 510(k) clearance K132547 for ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS), Substantially Equivalent on 2014-04-17. Applicant: Monarch Medical Technologies. Device class: 2.

Clearance details

Applicant: Monarch Medical Technologies
Product code: Code NDC
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2013-08-13
Decision date: 2014-04-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Silver Spring, MD, 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 Monarch Medical Technologies

view all

K241088 — EndoTool IV (3.1)2024-12-11
K142918 — EndoTool SubQ2015-04-24

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 K132547

K-number listed on FDA's recall record

Z-1786-2019 — Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.Class II·Ongoing·Monarch Medical Technologies·20190503

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132547.

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