Product code FRF— General Hospital
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
- Classification name
- Cleaner, Air, Medical Recirculating
- Device class
- Class 2
- Regulation
- 21 CFR 880.5045
- Advisory panel
- General Hospital
- Total cleared
- 53
- First cleared
- Most recent
Market context for product code FRF
FDA has cleared devices under product code FRF between 1976 and 2025, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2022
- 2020
- 2013
- 2008
- 2007
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code FRF
Recent clearances under product code FRF
- K251872 — Biomoneta Avata Rx
- K242102 — CerroZone Mini
- K240696 — Airdog X8 Air Purifier (KJ800F-X8)
- K223835 — MA-40, MA-112
- K222416 — RIA Safeguard
- K211507 — Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
- K220990 — Qorda QD1
- K220298 — CerroZone Mobile
- K200321 — Novaerus NV1050
- K130702 — AIRSONETT AIR-4
- K112728 — HEPAIRX VENTILATING AIR PURIFIER
- K081062 — AIRSONNETT AIRSHOWER AIR 3
- K072185 — AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
- K070722 — PLASMAIR, MODEL T2006
- K023693 — MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
- K012549 — ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
- K010616 — DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
- K002692 — DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
- K984116 — HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
- K981841 — BREATHE EASY, MODELS AD AND CD
- K974682 — MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
- K960966 — HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
- K953536 — SLANT/FIN HEPA CLEAR
- K944305 — FRIEDRICH ELECTRONIC AIR CLEANER
- K930521 — AIR CLEANERS WITH HEPA FILTRATION
- K942434 — BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
- K942683 — BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550
- K943238 — NORELCO CLEAN AIR SYSTEM
- K944927 — NORELCO CLEAN AIR SYSTEM CAS900
- K945161 — NORELCO CLEAN AIR SYSTEM CAS950
- K942512 — PA300
- K942686 — NORELCO CLEAN AIR SYSTEM MODEL CAM665
- K940573 — HEPA AIR CLEANER
- K925055 — POLLENEX HEPA AIR CLEANERS
- K925566 — HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300
- K930860 — HEPA 2500 AIR CLEANER
- K930420 — HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300
- K884472 — AIR-ELECTRONIC AIR CLEANER (FILTER)
- K872359 — ENVIRACAIRE MODEL EV-1
- K862432 — HEPACRON PUREAIR-ZONE SYSTEM
- K861299 — HYGIENIC AIR PURIFYING DEVICE
- K854817 — INSTAPURE
- K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER
- K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER
- K843435 — LABMASTER & CRSI 600
- K842973 — HAYFEVER HELMET
- K831067 — BREATHING ZONE
- K812320 — AIR ALIVE
- K813258 — ULTIMATE-AIRE
- K812656 — DOTRICH ELECTRONIC AIR CLEANER #C500AM
- K760921 — AIR PURIFIER
- K760879 — ROOM AIR PURIFIER (TEX-DYN)
- K760481 — FILTER, PARTICULATE ARRESTING
Data sourced from openFDA. This site is unofficial and independent of the FDA.