Cleared Traditional

K093192 - FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (FDA 510(k) Clearance)

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

K093192 · Advanced Vascular Dynamics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
126d
Days
Class 2
Risk

K093192 is an FDA 510(k) clearance for the FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Advanced Vascular Dynamics (Portland, US). The FDA issued a Cleared decision on February 12, 2010 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - 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 Advanced Vascular Dynamics devices

Submission Details

510(k) Number K093192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2009
Decision Date February 12, 2010
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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 - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 52
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K093192.
PADnet Xpress
K220527 · Collaborative Care Diagnostics, LLC, D.B.A. Biomedix · Oct 2022
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
K213730 · Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · Apr 2022
ASI Plethysmogrpah Analyzer
K200567 · Arterial Stiffness, Inc. · Feb 2021
Automated ankle brachial pressure index measuring device, MESI mTABLET system
K201046 · Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · Dec 2020
VitalScan ANS
K191266 · Medeia, Inc. · Jan 2020