K223486 is an FDA 510(k) clearance for the SafeBreak® Vascular. This device is classified as a Intravenous Catheter Force-activated Separation Device. (Class II - Special Controls, product code QOI).
Submitted by Lineus Medical (Fayetteville, US). The FDA issued a Cleared decision on May 19, 2023, 179 days after receiving the submission on November 21, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5220. An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement..
| 510(k) Number | K223486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2022 |
| Decision Date | May 19, 2023 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QOI - Intravenous Catheter Force-activated Separation Device. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5220 |
| Definition | An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement. |