Submission Details
| 510(k) Number | K200299 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2020 |
| Decision Date | October 29, 2020 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Curos Jet Disinfecting Cap
Oct 2020
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K200299 is an FDA 510(k) clearance for the Curos Jet Disinfecting Cap, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on October 29, 2020, 266 days after receiving the submission on February 6, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | QBP — Cap, Device Disinfectant |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time |
Manufacturer
Similar Devices — QBP Cap, Device Disinfectant
All 20
K251592 · 1World Vista Medical
· Feb 2026
K223914 · Cleansite Medical, Inc.
· Apr 2024
K193190 · Becton, Dickinson and Company
· Nov 2020
K192382 · Star Mountain Medical, Inc.
· Apr 2020
K190918 · Icu Medical
· Mar 2020
K142806 · Catheter Connections, Inc.
· May 2015
More from 3M Company
View all
K243501
· FRC · Jan 2025
K242538
· FRC · Nov 2024
K241959
· FRC · Oct 2024
K241710
· FRC · Sep 2024
K240717
· FRC · Jun 2024