Submission Details
| 510(k) Number | K223843 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2022 |
| Decision Date | May 03, 2023 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K223843 - FloPatch FP120
(FDA 510(k) Clearance)
May 2023
Decision
132d
Days
Class 2
Risk
K223843 is an FDA 510(k) clearance for the FloPatch FP120. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW).
Submitted by Flosonics Medical (Toronto, CA). The FDA issued a Cleared decision on May 3, 2023, 132 days after receiving the submission on December 22, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
Device Classification
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2100 |
Similar Devices — DPW Flowmeter, Blood, Cardiovascular
All 135
K251904 · Remington Medical, Inc.
· Nov 2025
K251114 · Flosonics Medical
· Jun 2025
K243852 · Elfi-Tech , Ltd.
· Apr 2025
K241583 · Remington Medical, Inc.
· Aug 2024
K222242 · Flosonics Medical
· Dec 2022
K213974 · Synovis Micro Companies Alliance, Inc.
· Apr 2022