FDA product code QBP: Cap, Device Disinfectant
QBP is the FDA product code for cap, device disinfectant. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 22 510(k) submissions under QBP, 3 in the last five years, from 13 different applicants. The average 510(k) review took 203 days (median 228); 366 days on average over the last three years. FDA has posted 2 recalls for QBP devices, 2 initiated in the last five years.
Definition
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Classification
| Field | Value |
|---|---|
| Device name | Cap, Device Disinfectant |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QBP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 4 | 297 |
| 2024 | 1 | 463 |
| 2026 | 2 | 268 |
Compare with all 510(k) review times · Search every QBP clearance
Top QBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Catheter Connections, Inc. | 7 | 2015-05-22 |
| Ivera Medical, Inc. | 3 | 2014-12-04 |
| Excelsior Medical Corp. | 2 | 2013-12-24 |
| Icu Medical, Inc. | 1 | 2026-03-27 |
| 1World Vista Medical | 1 | 2026-02-11 |
8 more applicants have QBP clearances. See the full list in Caduvo.
Most recent QBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252006 | Icu Medical, Inc. | OTTO Disinfecting Cap | 2026-03-27 | 273 |
| K251592 | 1World Vista Medical | SteriHub Disinfecting Device and Protective Cover | 2026-02-11 | 264 |
| K223914 | Cleansite Medical, Inc. | ACTIV Cap | 2024-04-05 | 463 |
| K193190 | Becton, Dickinson and Company | BD PureHub Disinfecting Cap | 2020-11-09 | 356 |
| K200299 | 3M Company | Curos Jet Disinfecting Cap | 2020-10-29 | 266 |
Recalls for QBP devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-06-16.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code QBP?
QBP is the FDA product code for cap, device disinfectant. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is QBP?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBP?
Across 22 cleared submissions the average was 203 days from receipt to decision (median 228).
Which companies have the most QBP clearances?
Catheter Connections, Inc. (7); Ivera Medical, Inc. (3); Excelsior Medical Corp. (2); Icu Medical, Inc. (1); 1World Vista Medical (1).
Have QBP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code QBP
- Run a recall and safety report across every QBP manufacturer
- Watch product code QBP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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