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

Alarm, Conditioned Response Enuresis

21 CFR 876.2040 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KPN is the FDA product code for Alarm, Conditioned Response Enuresis, a class II device type, regulated under 21 CFR 876.2040. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KPN
Device name
Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
37
Ingested recalls
4

Clearances, product code KPN

By decision year
37 clearances under product code KPN with a decision year between 1978 and 2013, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KPN by decision year
YearClearances
19781
19791
19822
19842
19853
19863
19872
19882
19893
19904
19911
19921
19932
19942
19952
19963
19971
19981
20131

Applicants with the most clearances

Product code KPN
Applicants holding the most 510(k) clearances under product code KPN
ApplicantClearances
Health Sense Intl., Inc.4
Biosonics, Inc.3
Travis Industries, Inc.3
Abbott Medical2
Nite Train-R Enterprises, Inc.2
Bio-Systems Research1
C.R. Bard Inc1
Conklin Technology, Inc.1
Digital Applications, Inc.1
Dilorenzo Engineering Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order