Cleared Traditional

K073323 - SA-3000P (FDA 510(k) Clearance)

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

K073323 · Medicore Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
2d
Days
Class 2
Risk

K073323 is an FDA 510(k) clearance for the SA-3000P. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Medicore Co., Ltd. (Gangnam-Gu, Seoul, KR). The FDA issued a Cleared decision on November 29, 2007 after a review of 2 days - a notably fast clearance cycle.

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: 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 Medicore Co., Ltd. devices

Submission Details

510(k) Number K073323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2007
Decision Date November 29, 2007
Days to Decision 2 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
123d faster than avg
Panel avg: 125d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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
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