510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KMAClass I

Irrigator, Powered Nasal

21 CFR 874.5550 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KMA is the FDA product code for Irrigator, Powered Nasal, a class I device type, regulated under 21 CFR 874.5550. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KMA
Device name
Irrigator, Powered Nasal
Regulation
21 CFR 874.5550
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
1

Clearances, product code KMA

By decision year
5 clearances under product code KMA with a decision year between 1982 and 2014, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KMA by decision year
YearClearances
19821
19951
19961
19981
20141

Applicants with the most clearances

Product code KMA
Applicants holding the most 510(k) clearances under product code KMA
ApplicantClearances
Respironics, Inc.2
JEDMED Instrument Company1
Kelleher Corp.1
Rhinosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order