Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KXF — Predicate Candidate Screening

21 FDA 510(k) clearances under this product code; the 50 most recent screened below.

35 daysmedian FDA review time

98 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K123184	FINN CHAMBERS AQUA	Smartpractice	2012-12-19	70
K103409	ALLERGEAZE R CLEAR	Smartpractice	2011-03-15	113
K063160	ALLERGEAZE PATCH TEST CHAMBERS	Smartpractice	2006-12-22	66
K013820	FINN CHAMBER (R)	Epitest Ltd. OY	2002-01-30	75
K992553	IQ CHAMBERS	Dormer Laboratories, Inc.	2000-04-12	257
K870762	EAR APPLICATOR, CATALOG NO. 2229	Treace Medical, Inc.	1987-03-06	8
K843720	COTTON TIPPED APPLICATORS, SINGLE	Abco Dealers, Inc.	1984-10-04	10
K820962	COTTON SWABS	Dafoe & Dafoe, Inc.	1982-04-20	14
K813506	FARRORS TMJ CASSETTE HOLDER	Brell Mar Products, Inc.	1982-01-29	45
K811365	HILL TOP CHAMBER	Hill Top Research, Inc.	1981-08-20	98
K802580	SUBCLAVIAN CATHETER INSERTION TRAY	American Pharmaseal Div. Ahsc	1980-11-12	28
K802016	EYE APPLICATORS CAT.#980-983	Pollak (Intl.), Ltd.	1980-09-16	27
K802020	PREP SET CAT.#908	Pollak (Intl.), Ltd.	1980-09-09	20
K791168	DEXIDE DISPOSABLE PREP STICK	Dexide, Inc.	1979-07-30	35
K791169	DEXIDE DISPOSABLE SWAB STICK	Dexide, Inc.	1979-07-30	35
K780929	COTTON TIPPED POINT	Young Dental Manufacturing Co. 1, LLC	1978-06-30	25
K780604	SHAVE PREP	Abco Dealers, Inc.	1978-04-19	9
K772298	SEXUAL ASSAULT FORENCIC EVIDENCE KIT	Simpson/Basye, Inc.	1978-03-02	79
K772227	CATH KIT, SUPERPUBIC	American Hospital Supply Corp.	1977-12-20	14
K770583	MEDI-PAK LEMON GLYCEOIN SWABS	General Medical Co.	1977-05-26	59
K770433	Q-TIPS	Chesebrough-Pond'S U.S.A. Co.	1977-04-15	39

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda