QBPClass II
Cap, Device Disinfectant
21 CFR 880.5440 / General Hospital
QBP is the FDA product code for Cap, Device Disinfectant, a class II device type, regulated under 21 CFR 880.5440. FDA's definition for this code reads: "Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- QBP
- Device name
- Cap, Device Disinfectant
- FDA definition
- Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
- Regulation
- 21 CFR 880.5440
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 22
- Ingested recalls
- 2
Clearances, product code QBP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2020 | 4 |
| 2024 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code QBP| Applicant | Clearances |
|---|---|
| Catheter Connections, Inc. | 7 |
| Ivera Medical, Inc. | 4 |
| Abbott Medical | 3 |
| Excelsior Medical LLC | 2 |
| 122 Corporation | 1 |
| 1World Vista Medical | 1 |
| 3M Company | 1 |
| Becton Dickinson & Co | 1 |
| Cleansite Medical, Inc. | 1 |
| Star Mountain Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Amsino Medical (Shanghai) Co., Ltd.
- Becton Dickinson & Co
- Excelsior Medical LLC
- Health Line International Corporation
- ICU MEDICAL de MEXICO, S. de R.L. de C.V.
- Isomedix Operations Inc
- Medtronic, Inc.
- Merit Medical Asia Company Limited
- Merit Medical Australia Pty Ltd.
- Merit Medical Canada Ltd.
- Merit Medical Nederland BV
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
