Hamilton-TC1

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Also cleared against K102775: 1 other device →

2 later devices cite 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.

• K062267Oxylog 3000Drager Medical B.V. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 13 Class I recalls
• K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
• K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
• K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
• K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
• K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
• K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
• K120670Hamilton-T1Hamilton Medical AG · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
• K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
• K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
• K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
• K153046Hamilton-MR1Hamilton Medical AG · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 12 of 14 shown.

Nearest 5 of 14; all are on the web page.

What does this lineage say?

• The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
• 26 of the 82 ancestors have a recall of any class; 7 have a Class I recall.
• Of its descendants, K120670 (Hamilton Medical AG, 2012) has gone furthest, with 11 descendants of its own.
• 1 other device also cites its predicate K102775.

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

What is it indicated for?

Indications for use as stated in the FDA summary.