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

Monitor, Pressure, Intrauterine

21 CFR 884.2700 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

KXO is the FDA product code for Monitor, Pressure, Intrauterine, a class II device type, regulated under 21 CFR 884.2700. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KXO
Device name
Monitor, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
26
Ingested recalls
0

Clearances, product code KXO

By decision year
26 clearances under product code KXO with a decision year between 1979 and 1999, 1989 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KXO by decision year
YearClearances
19792
19801
19862
19871
19881
19895
19902
19912
19922
19941
19952
19961
19971
19982
19991

Applicants with the most clearances

Product code KXO
Applicants holding the most 510(k) clearances under product code KXO
ApplicantClearances
Graphic Controls Corp.5
Spectramed, LLC4
Medex, Inc.3
Healthdyne Cardiovascular, Inc.2
Telos Medical Corp.2
Utah Medical Products, Inc2
Carl Schuh1
GE Medical Systems Information Technologies, Inc.1
Hewlett-Packard Co.1
Ludlow Technical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code