QBP · Class II · 21 CFR 880.5440

FDA Product Code QBP: Cap, Device Disinfectant

Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time

Leading manufacturers include Catheter Connections, Inc., Ivera Medical, Inc. and Excelsior Medical Corp..

22
Total
22
Cleared
203d
Avg days
2008
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 269d recently vs 196d historically

FDA 510(k) Cleared Cap, Device Disinfectant Devices (Product Code QBP)

22 devices
1–22 of 22
Cleared Mar 27, 2026
OTTO™ Disinfecting Cap
K252006
Icu Medical, Inc.
General Hospital · 273d
Cleared Feb 11, 2026
SteriHub™ Disinfecting Device and Protective Cover
K251592
1World Vista Medical
General Hospital · 264d
Cleared Apr 05, 2024
ACTIV™ Cap
K223914
Cleansite Medical, Inc.
General Hospital · 463d
Cleared Nov 09, 2020
BD PureHub Disinfecting Cap
K193190
Becton, Dickinson and Company
General Hospital · 356d
Cleared Oct 29, 2020
Curos Jet Disinfecting Cap
K200299
3M Company
General Hospital · 266d
Cleared Apr 20, 2020
CapKlenZ
K192382
Star Mountain Medical, Inc.
General Hospital · 234d
Cleared Mar 06, 2020
SwabTip Male Disinfectant Cap
K190918
Icu Medical
General Hospital · 332d
Cleared May 22, 2015
DualCap
K142806
Catheter Connections, Inc.
General Hospital · 235d
Cleared Dec 04, 2014
CUROS RED PORT PROTECTOR
K140657
Ivera Medical, Inc.
General Hospital · 265d
Cleared Nov 19, 2014
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
K142399
Catheter Connections, Inc.
General Hospital · 84d
Cleared Dec 24, 2013
SWABCAP AND SWABFLUSH
K130975
Excelsior Medical Corp.
General & Plastic Surgery · 260d
Cleared Jan 22, 2013
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
K123967
Catheter Connections, Inc.
General Hospital · 27d
Cleared Dec 14, 2012
CATHETER CONNECTIONS DUALCAP SOLO
K123065
Catheter Connections, Inc.
General Hospital · 74d
Cleared Nov 26, 2012
CUROS TIP
K121171
Ivera Medical, Inc.
General Hospital · 223d
Cleared Jan 27, 2012
CATHETER CONNECTIONS' DUALCAP SOLO
K113842
Catheter Connections, Inc.
General Hospital · 30d
Cleared Jan 12, 2012
CUROS PORT PROTECTOR
K111992
Ivera Medical, Inc.
General Hospital · 183d
Cleared Nov 09, 2011
CATHETER CONNECTIONS' DUALCAP DUO
K112985
Catheter Connections, Inc.
General Hospital · 34d
Cleared Jun 23, 2011
CUROS PORT PROTECTOR
K110826
Ivera Medical
General Hospital · 91d
Cleared Apr 08, 2010
CATHETER CONNECTIONS DUALCAP
K093229
Catheter Connections, Inc.
General Hospital · 176d
Cleared Apr 28, 2009
SWABCAP
K083508
Excelsior Medical Corp.
General Hospital · 153d
Cleared Oct 21, 2008
ALCOHOL PAD
K080466
122 Corporation
General Hospital · 243d
Cleared Sep 11, 2008
EFFECTIV (TM) CAP
K080579
Hospira, Inc.
General Hospital · 192d

About Product Code QBP - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code QBP since 2008, with 22 receiving FDA clearance (average review time: 203 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QBP Product Code

Recent submissions under QBP have taken an average of 269 days to reach a decision - up from 196 days historically. Manufacturers should account for longer review timelines in current project planning.

QBP devices are reviewed by the General Hospital panel. Browse all General Hospital devices →