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

Purifier, Air, Ultraviolet, Medical

21 CFR 880.6500 / General Hospital
FDA source (opens on fda.gov)

FRA is the FDA product code for Purifier, Air, Ultraviolet, Medical, a class II device type, regulated under 21 CFR 880.6500. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FRA
Device name
Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
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
36
Ingested recalls
0

Clearances, product code FRA

By decision year
36 clearances under product code FRA with a decision year between 1987 and 2025, 2021 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FRA by decision year
YearClearances
19871
19881
19931
19943
19952
19962
19971
19991
20031
20041
20062
20141
20171
20202
20215
20224
20232
20244
20251

Applicants with the most clearances

Product code FRA
Applicants holding the most 510(k) clearances under product code FRA
ApplicantClearances
Molekule, Inc.3
Aeroclean Technologies, Inc.2
Healkee Medical Pte. Ltd.2
Schiff & Co.2
Abracair, Inc.1
Aerobiotix, Inc.1
Aerus Medical, LLC1
Airgle Corporation1
Allseasons Environmental Control, Inc.1
Applied Photonix LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order