Cleared Traditional

K023238 - MCPULSE

K023238 is an FDA 510(k) clearance for MCPULSE, manufactured by Meridian Co., Ltd.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K023238 · Meridian Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
145d
Days
Class 2
Risk

K023238 is an FDA 510(k) clearance for the MCPULSE. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Meridian Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on February 19, 2003 after a review of 145 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.

FDA 510(k) Submission Details - K023238

510(k) Number K023238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date February 19, 2003
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOM Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K023238.
SA-3000P
K073323 · Medicore Co., Ltd. · Nov 2007
PADNET+
K073146 · Biomedix, Inc. · Nov 2007
BIOMEDIX PADNET LAB
K042616 · Biomedix, Inc. · Oct 2004
A16 BLOOD FLOW MEASUREMENT SYSTEM
K023707 · D. E. Hokanson, Inc. · Feb 2003
PHLEBOTEST 2000
K022047 · Osborn Medical Corp. · Nov 2002
PVR-100/VASOGRAM
K990123 · Vasocor, Inc. · Apr 1999
K023238 · MCPULSE
Download PDF FDA Summary Meridian Co., Ltd.