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

Cleaner, Air, Medical Recirculating

21 CFR 880.5045 / General Hospital
FDA source (opens on fda.gov)

FRF is the FDA product code for Cleaner, Air, Medical Recirculating, a class II device type, regulated under 21 CFR 880.5045. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FRF
Device name
Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
53
Ingested recalls
1

Clearances, product code FRF

By decision year
53 clearances under product code FRF with a decision year between 1976 and 2025, 1994 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code FRF by decision year
YearClearances
19763
19811
19822
19831
19841
19853
19863
19871
19891
19932
199410
19953
19971
19982
19991
20001
20011
20021
20031
20071
20082
20132
20201
20223
20232
20242
20251

Applicants with the most clearances

Product code FRF
Applicants holding the most 510(k) clearances under product code FRF
ApplicantClearances
Airsonett AB2
Bionaire Corp.2
Cerrozone2
Hmi Industries, Inc.2
Medicor USA, Ltd.2
Norelco Consumer Products Co.2
The Rival Co.2
Abatement Technologies Limited1
Air Innovations, Inc.1
Airex, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code