Cleared Traditional

K200337 - FloPatch (FP120)

K200337 is the FDA 510(k) clearance for FloPatch (FP120) by Flosonics Medical (R/A 1929803 Ontario Corp.). It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K200337 · Flosonics Medical (R/A 1929803 Ontario Corp.) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
42d
Days
Class 2
Risk

K200337 is an FDA 510(k) clearance for the FloPatch (FP120). Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Flosonics Medical (R/A 1929803 Ontario Corp.) (Toronto, CA). The FDA issued a Cleared decision on March 24, 2020 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Flosonics Medical (R/A 1929803 Ontario Corp.) devices

Submission Details

510(k) Number K200337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2020
Decision Date March 24, 2020
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 33
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K200337.
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
K211589 · Remington Medical, Inc. · Jan 2022
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
K212065 · Remington Medical, Inc. · Oct 2021
Bidop 7
K201114 · Koven Technology, Inc. · Jan 2021
FlowMet
K192966 · Laser Associated Sciences, Inc. · Jan 2020
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574 · Huntleigh Healthcare , Ltd. · Sep 2019
FloPatch (FP110)
K191388 · Flosonics Medical (R/A 1929803 Ontario Corp.) · Jun 2019