Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LKB — Predicate Candidate Screening

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

68 daysmedian FDA review time

246 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K132380	PREVANTICS DEVICE SWAB	Professional Disposables International, Inc.	2014-08-27	392
K121655	BD ALCOHOL SWAB	Becton, Dickinson & CO	2013-03-20	288
K112791	SITESCRUB IPA DEVICE	C. R. Bard	2012-02-24	151
K912161	I.V. STARR KIT	Medical Device Inspection Co., Inc.	1991-10-08	145
K912731	STERI-SWAB	Westlock Investments (Usa), Inc.	1991-10-02	104
K910735	HEXIDIS ALCOHOL SWAB	Specialites Septodont	1991-04-02	40
K896898	BOWEN ELECTRODE SKIN PREPATORY CLEANSER	Bowen & Company, Inc.	1990-04-04	117
K896835	ALCOHOL PREP AND POVIDONE-IODINE PREP	Norpak Mfg., Inc.	1990-01-11	37
K893958	BAXTER ACETONE-ALCOHOL PREP PADS, STERILE	Span-America Medical Systems, Inc.	1989-10-03	124
K894791	BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE	Span-America Medical Systems, Inc.	1989-10-03	67
K892193	QUICKPAD (ALCOHOL SWABS)	Holtsch Co., Inc.	1989-08-04	121
K883840	DRI-VENT ARTERIAL BLOOD SAMPLING KIT	Concord Laboratories, Inc.	1989-05-16	246
K890514	PRE-MOISTENED CLEANSING PAD	Bausch & Lomb, Inc.	1989-04-10	68
K870718	AMERICAN ALCOHOL PREP PAD STERILE MEDIUM	Span-America Medical Systems, Inc.	1987-05-07	76
K860961	GAMMA RADIATION STERILIZED ALCOHOL PREP PADS	H & P Industries, Inc.	1986-04-09	27
K852235	STERETS INJECTION SWAB	Ellis Pharmaceutical Consulting, Inc.	1985-06-07	16
K833993	ALCOHOL SWABS	Concord Laboratories, Inc.	1984-01-30	70
K833936	ACETONE ALCOHOL SWABS	Concord Laboratories, Inc.	1984-01-30	76
K833185	ACETONE ALCOHOL PREP PAD	Aplicare, Inc.	1983-10-31	42
K833141	ONE TIME ACETONE/ALCOHOL;SWAB STICKS	Acme United Corp.	1983-10-31	47
K833183	APLICARE ONE ACETONE ALCOHOL SWABSTICK	Aplicare, Inc.	1983-10-31	42
K833184	APLICARE THREE ALCOHOL SWABSTICKS	Aplicare, Inc.	1983-10-27	38
K833182	APLICARE ALCOHOL PREP PAD	Aplicare, Inc.	1983-10-27	38
K830330	SAVETT ALCOHOL PREP	Cederroth, Inc. USA	1983-03-17	44
K813391	TOBRAMYCIN REAGENT TEST KIT	Beckman Instruments, Inc.	1981-12-18	15

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