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

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

21 CFR 868.2500 / Anesthesiology
FDA source (opens on fda.gov)

KLK is the FDA product code for Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, a class II device type, regulated under 21 CFR 868.2500. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KLK
Device name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
47
Ingested recalls
3

Clearances, product code KLK

By decision year
47 clearances under product code KLK with a decision year between 1978 and 2001, 1984 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code KLK by decision year
YearClearances
19782
19795
19803
19816
19825
19834
19848
19853
19863
19871
19891
19931
19951
19961
19981
19991
20011

Applicants with the most clearances

Product code KLK
Applicants holding the most 510(k) clearances under product code KLK
ApplicantClearances
Novametrix Medical Systems, Inc.13
Biochem International, Inc.3
Critikon Company, LLC2
GE Medical Systems Information Technologies, Inc.2
Hewlett-Packard Co.2
Instrumentation Laboratory Co.2
Linde Medical Sensors AG2
Mennen Medical, Inc.2
Sumitomo Electric Industries, Inc.2
Air-Shields Vickers, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order