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

Humidifier, Non-Direct Patient Interface (Home-Use)

21 CFR 868.5460 / Anesthesiology
FDA source (opens on fda.gov)

KFZ is the FDA product code for Humidifier, Non-Direct Patient Interface (Home-Use), a class I device type, regulated under 21 CFR 868.5460. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KFZ
Device name
Humidifier, Non-Direct Patient Interface (Home-Use)
Regulation
21 CFR 868.5460
Device class
Class I
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
20
Ingested recalls
3

Clearances, product code KFZ

By decision year
20 clearances under product code KFZ with a decision year between 1976 and 1995, 1985 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KFZ by decision year
YearClearances
19761
19781
19791
19812
19832
19842
19853
19863
19872
19901
19921
19951

Applicants with the most clearances

Product code KFZ
Applicants holding the most 510(k) clearances under product code KFZ
ApplicantClearances
Airlife, Inc.2
Associated Mills, Inc.2
Mistogen Equipment Co.2
Ascot Pharmaceuticals, Inc.1
Douglas Products1
Hankscraft Div. of Gerber Products Co.1
Kaz, Inc.1
Med USA1
Northern Electric Co. Div. of Sunbeam Corp.1
Respirizer Co., Div. Campillary Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 115 companies shown, in name order