Atlas FDA

LKB

25 FDA 510(k) clearances · Product code

68 daysmedian time to decision
246 days90th percentile
25clearances measured

FDA profile

Official device name
Pad, Alcohol, Device Disinfectant
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2018: 21 · 2019: 37 · 2020: 39 · 2021: 40 · 2023: 29 · 2026: 56
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PREVANTICS DEVICE SWAB (K132380)Professional Disposables International, Inc.2014-08-27
BD ALCOHOL SWAB (K121655)Becton, Dickinson & CO2013-03-20
SITESCRUB IPA DEVICE (K112791)C. R. Bard2012-02-24
I.V. STARR KIT (K912161)Medical Device Inspection Co., Inc.1991-10-08
STERI-SWAB (K912731)Westlock Investments (Usa), Inc.1991-10-02
HEXIDIS ALCOHOL SWAB (K910735)Specialites Septodont1991-04-02
BOWEN ELECTRODE SKIN PREPATORY CLEANSER (K896898)Bowen & Company, Inc.1990-04-04
ALCOHOL PREP AND POVIDONE-IODINE PREP (K896835)Norpak Mfg., Inc.1990-01-11
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (K893958)Span-America Medical Systems, Inc.1989-10-03
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE (K894791)Span-America Medical Systems, Inc.1989-10-03
QUICKPAD (ALCOHOL SWABS) (K892193)Holtsch Co., Inc.1989-08-04
DRI-VENT ARTERIAL BLOOD SAMPLING KIT (K883840)Concord Laboratories, Inc.1989-05-16
PRE-MOISTENED CLEANSING PAD (K890514)Bausch & Lomb, Inc.1989-04-10
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM (K870718)Span-America Medical Systems, Inc.1987-05-07
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS (K860961)H & P Industries, Inc.1986-04-09
STERETS INJECTION SWAB (K852235)Ellis Pharmaceutical Consulting, Inc.1985-06-07
ALCOHOL SWABS (K833993)Concord Laboratories, Inc.1984-01-30
ACETONE ALCOHOL SWABS (K833936)Concord Laboratories, Inc.1984-01-30
ACETONE ALCOHOL PREP PAD (K833185)Aplicare, Inc.1983-10-31
ONE TIME ACETONE/ALCOHOL;SWAB STICKS (K833141)Acme United Corp.1983-10-31
APLICARE ONE ACETONE ALCOHOL SWABSTICK (K833183)Aplicare, Inc.1983-10-31
APLICARE THREE ALCOHOL SWABSTICKS (K833184)Aplicare, Inc.1983-10-27
APLICARE ALCOHOL PREP PAD (K833182)Aplicare, Inc.1983-10-27
SAVETT ALCOHOL PREP (K830330)Cederroth, Inc. USA1983-03-17
TOBRAMYCIN REAGENT TEST KIT (K813391)Beckman Instruments, Inc.1981-12-18

Track LKB automatically

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