Cleared Traditional

K922669 - MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922669 · Koven and Assoc., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
239d
Days
Class 2
Risk

K922669 is an FDA 510(k) clearance for the MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Koven and Assoc., Inc. (St. Louis, US). The FDA issued a Cleared decision on January 29, 1993 after a review of 239 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Koven and Assoc., Inc. devices

Submission Details

510(k) Number K922669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date January 29, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 125d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DPW Flowmeter, Blood, Cardiovascular

All 136
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K922669.
FloPatch FP120
K252810 · Flosonics Medical · Apr 2026
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01)
K251904 · Remington Medical, Inc. · Nov 2025
FloPatch FP120
K251114 · Flosonics Medical · Jun 2025
Elfor-L
K243852 · Elfi-Tech , Ltd. · Apr 2025
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01)
K241583 · Remington Medical, Inc. · Aug 2024
FloPatch FP120
K223843 · Flosonics Medical · May 2023