KXF

21 FDA 510(k) clearances · Product code

35 daysmedian time to decision

98 days90th percentile

21clearances measured

FDA profile

Official device name: Applicator, Absorbent Tipped, Non-Sterile
Device class: Class I (low risk)
Regulation: 21 CFR 880.6025
Medical specialty: General Hospital
Flags: GMP exempt
Adverse events (MAUDE): 2016: 11 · 2017: 18 · 2020: 64 · 2021: 134 · 2022: 13 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Record	Firm	Date
FINN CHAMBERS AQUA (K123184)	Smartpractice	2012-12-19
ALLERGEAZE R CLEAR (K103409)	Smartpractice	2011-03-15
ALLERGEAZE PATCH TEST CHAMBERS (K063160)	Smartpractice	2006-12-22
FINN CHAMBER (R) (K013820)	Epitest Ltd. OY	2002-01-30
IQ CHAMBERS (K992553)	Dormer Laboratories, Inc.	2000-04-12
EAR APPLICATOR, CATALOG NO. 2229 (K870762)	Treace Medical, Inc.	1987-03-06
COTTON TIPPED APPLICATORS, SINGLE (K843720)	Abco Dealers, Inc.	1984-10-04
COTTON SWABS (K820962)	Dafoe & Dafoe, Inc.	1982-04-20
FARRORS TMJ CASSETTE HOLDER (K813506)	Brell Mar Products, Inc.	1982-01-29
HILL TOP CHAMBER (K811365)	Hill Top Research, Inc.	1981-08-20
SUBCLAVIAN CATHETER INSERTION TRAY (K802580)	American Pharmaseal Div. Ahsc	1980-11-12
EYE APPLICATORS CAT.#980-983 (K802016)	Pollak (Intl.), Ltd.	1980-09-16
PREP SET CAT.#908 (K802020)	Pollak (Intl.), Ltd.	1980-09-09
DEXIDE DISPOSABLE PREP STICK (K791168)	Dexide, Inc.	1979-07-30
DEXIDE DISPOSABLE SWAB STICK (K791169)	Dexide, Inc.	1979-07-30
COTTON TIPPED POINT (K780929)	Young Dental Manufacturing Co. 1, LLC	1978-06-30
SHAVE PREP (K780604)	Abco Dealers, Inc.	1978-04-19
SEXUAL ASSAULT FORENCIC EVIDENCE KIT (K772298)	Simpson/Basye, Inc.	1978-03-02
CATH KIT, SUPERPUBIC (K772227)	American Hospital Supply Corp.	1977-12-20
MEDI-PAK LEMON GLYCEOIN SWABS (K770583)	General Medical Co.	1977-05-26
Q-TIPS (K770433)	Chesebrough-Pond'S U.S.A. Co.	1977-04-15

Every clearance here is in the API, with alerts when new ones post.