Verifuse Ambulatory Pump

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

1 later device cites it directly; ranked here by how many devices descend from each in turn.

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

• K994375Horizon LightB.Braun Medical, Inc. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 11 Class I recall
• K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations on · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
• K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
• K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
• K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
• K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
• K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
• K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
• K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
• K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
• K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
• K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

Nearest 12 of 17 shown.

Nearest 5 of 17; all are on the web page.

What does this lineage say?

• Of its descendants, K994375 (B.Braun Medical, Inc., 2000) has gone furthest, with 65 descendants of its own.

MEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.