MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS— 510(k) K012171

Name: FDA 510(k) clearance K012171
Creator: U.S. Food and Drug Administration
Published: 2001-07-24

Substantially Equivalent

Visicu, Inc.

FDA 510(k) clearance K012171 for MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS, Substantially Equivalent on 2001-07-24. Applicant: Visicu, Inc.. Device class: 2.

Clearance details

Applicant: Visicu, Inc.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2001-07-12
Decision date: 2001-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30
K243270 — TigerConnect Alarm Management2025-09-30
K242728 — BeneVision Central Monitoring System2025-07-31

More clearances from Visicu, Inc.

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K211046 — eCareManager 4.52022-06-03
K171322 — eCareManager 4.12017-08-03
K171029 — eCareCoordinator2017-07-14
K153156 — eCareManager 4.0.12016-09-30
K141706 — ECARE COORDINATOR (ECC)2014-09-09

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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 K012171

K-number listed on FDA's recall record

Z-0399-2016 — The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.Class II·Terminated·Visicu, Inc.·20150327

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012171.

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