Cleared Traditional

K110374 - MAX PULSE SYSTEM

K110374 is an FDA 510(k) clearance for MAX PULSE SYSTEM, manufactured by Medicore Co., Ltd.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K110374 · Medicore Co., Ltd. · Cardiovascular device
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Jun 2011
Decision
124d
Days
Class 2
Risk

K110374 is an FDA 510(k) clearance for the MAX PULSE SYSTEM. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Medicore Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on June 13, 2011 after a review of 124 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 Medicore Co., Ltd. devices

FDA 510(k) Submission Details - K110374

510(k) Number K110374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2011
Decision Date June 13, 2011
Days to Decision 124 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 125d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 8
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K110374.
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