510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LIXClass II

Aid, Cardiopulmonary Resuscitation

21 CFR 870.5210 / Cardiovascular
FDA source (opens on fda.gov)

LIX is the FDA product code for Aid, Cardiopulmonary Resuscitation, a class II device type, regulated under 21 CFR 870.5210. FDA's definition for this code reads: "CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software". As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LIX
Device name
Aid, Cardiopulmonary Resuscitation
FDA definition
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software
Regulation
21 CFR 870.5210
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
2

Clearances, product code LIX

By decision year
17 clearances under product code LIX with a decision year between 1984 and 2021, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LIX by decision year
YearClearances
19841
19851
19901
19931
19961
20012
20071
20091
20122
20132
20151
20182
20211

Applicants with the most clearances

Product code LIX
Applicants holding the most 510(k) clearances under product code LIX
ApplicantClearances
Laerdal Medical a/S4
ZOLL Medical Corporation2
Avantech, Inc.1
Can-Am Medical, Inc.1
County Line, Ltd.1
Credo1
Elcare Innovations, Inc.1
James J. Lally1
Kells Medical, Inc.1
Lifepoint,Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order