510(k) Report

FDA applicant

Visicu, Inc.

Baltimore, MD7 decisions2000–20224 recalls

FDA records 7 decisions for Visicu, Inc. (Baltimore, MD) from 2000 to 2022: 7 510(k) clearances. Most are in product codes MSX (System, Network And Communication…) and DRG (Transmitters And Receivers, Physiological…). Since 2016 its 510(k)s took a median of 333 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Visicu, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12016: 12017: 22022: 1
2007high 2 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2012: 12015: 12016: 12017: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Visicu, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Visicu, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MSXSystem, Network And Communication, Physiological Monitors5decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 333 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 174 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012171Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsVisicu, Inc. · 20013cite it
  • K171322eCareManager 4.1Visicu, Inc. · 20172cite it
  • K153156eCareManager 4.0.1Visicu, Inc. · 20161cites it
  • K141706Ecare Coordinator (Ecc)Visicu, Inc. · 20141cites it
  • K001972Argus System-Continuous Expert Care NetworkVisicu, Inc. · 20001cites it
  • K171029eCareCoordinatorVisicu, Inc. · 20171cites it

What has FDA decided for it lately?

  • K211046eCareManager 4.5Visicu, Inc. · 2022
  • K171322eCareManager 4.1Visicu, Inc. · 2017
  • K171029eCareCoordinatorVisicu, Inc. · 2017
  • K153156eCareManager 4.0.1Visicu, Inc. · 2016
  • K141706Ecare Coordinator (Ecc)Visicu, Inc. · 20142 recalls
  • K012171Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsVisicu, Inc. · 20012 recalls
  • K001972Argus System-Continuous Expert Care NetworkVisicu, Inc. · 20002 recalls

All 7 as Visicu, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K141706eCare Coordinator Product Usage: is software intended for use in data aggregation…Mar 2, 2017Class II
  • K141706eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight…Mar 10, 2016Class II
  • K001972The eCareManager system. Software intended for use in data collection, storage and…Mar 27, 2015Class II
  • K001972Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product…Feb 22, 2012