Atlas FDA

QBP

22 FDA 510(k) clearances · Product code

234 daysmedian time to decision
332 days90th percentile
22clearances measured

FDA profile

Official device name
Cap, Device Disinfectant
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
FDA definition
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
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RecordFirmDate
OTTO™ Disinfecting Cap (K252006)Icu Medical, Inc.2026-03-27
SteriHub™ Disinfecting Device and Protective Cover (K251592)1World Vista Medical2026-02-11
ACTIV™ Cap (K223914)Cleansite Medical, Inc.2024-04-05
BD PureHub Disinfecting Cap (K193190)Becton, Dickinson and Company2020-11-09
Curos Jet Disinfecting Cap (K200299)3M Company2020-10-29
CapKlenZ (K192382)Star Mountain Medical, Inc.2020-04-20
SwabTip Male Disinfectant Cap (K190918)Icu Medical2020-03-06
DualCap (K142806)Catheter Connections, Inc.2015-05-22
CUROS RED PORT PROTECTOR (K140657)Ivera Medical, Inc.2014-12-04
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (K142399)Catheter Connections, Inc.2014-11-19
SWABCAP AND SWABFLUSH (K130975)Excelsior Medical Corp.2013-12-24
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (K123967)Catheter Connections, Inc.2013-01-22
CATHETER CONNECTIONS DUALCAP SOLO (K123065)Catheter Connections, Inc.2012-12-14
CUROS TIP (K121171)Ivera Medical, Inc.2012-11-26
CATHETER CONNECTIONS' DUALCAP SOLO (K113842)Catheter Connections, Inc.2012-01-27
CUROS PORT PROTECTOR (K111992)Ivera Medical, Inc.2012-01-12
CATHETER CONNECTIONS' DUALCAP DUO (K112985)Catheter Connections, Inc.2011-11-09
CUROS PORT PROTECTOR (K110826)Ivera Medical2011-06-23
CATHETER CONNECTIONS DUALCAP (K093229)Catheter Connections, Inc.2010-04-08
SWABCAP (K083508)Excelsior Medical Corp.2009-04-28
ALCOHOL PAD (K080466)122 Corporation2008-10-21
EFFECTIV (TM) CAP (K080579)Hospira, Inc.2008-09-11

Track QBP automatically

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