Cleared Traditional

K062364 - I-SCOPE 200

K062364 is an FDA 510(k) clearance for I-SCOPE 200, manufactured by Dongjin Medical Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K062364 · Dongjin Medical Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
114d
Days
Class 2
Risk

K062364 is an FDA 510(k) clearance for the I-SCOPE 200. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Dongjin Medical Co., Ltd. (Sungnam-Si, Kyunggi-Do, KR). The FDA issued a Cleared decision on December 6, 2006 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 - K062364

510(k) Number K062364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date December 06, 2006
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

All 141
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K062364.
TR-USB TELEPHONIC STETHOSCOPE
K081032 · Rnk Products, Inc. · Jun 2008
AUSCO ES-3100
K070550 · Koratek Company, Ltd. · Nov 2007
RNK ELECTRONIC STETHOSCOPE
K072026 · Rnk Products, Inc. · Oct 2007
SERENO ELECTRONIC STETHOSCOPE
K062481 · Pishon High Tech Co., Ltd. · Oct 2006
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · American Diagnostic Corp. · May 2006
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
K060197 · Zargis Medical Corp. · Mar 2006
K062364 · I-SCOPE 200
Download PDF FDA Summary Dongjin Medical Co., …