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

Monitor, Carbon-Dioxide, Cutaneous

21 CFR 868.2480 / Anesthesiology
FDA source (opens on fda.gov)

LKD is the FDA product code for Monitor, Carbon-Dioxide, Cutaneous, a class II device type, regulated under 21 CFR 868.2480. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
LKD
Device name
Monitor, Carbon-Dioxide, Cutaneous
Regulation
21 CFR 868.2480
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
23

Clearances, product code LKD

By decision year
17 clearances under product code LKD with a decision year between 1988 and 2024, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LKD by decision year
YearClearances
19881
19892
19901
19911
19941
19981
19991
20041
20052
20102
20111
20131
20151
20241

Applicants with the most clearances

Product code LKD
Applicants holding the most 510(k) clearances under product code LKD
ApplicantClearances
Sentec AG4
Perimed AB2
Radiometer Medical ApS2
GE Medical Systems Information Technologies, Inc.1
Hewlett-Packard Co.1
Linde Medical Sensors AG1
Novametrix Medical Systems, Inc.1
Philips Medizinsysteme Boeblingen GmbH, Cardiac an1
Radiometer America, Inc1
S & W Medico Teknik1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order