Cleared Traditional

K200649 - Arm-Type Fully Automatic Digital Blood ...

K200649 is the FDA 510(k) clearance for Arm-Type Fully Automatic Digital Blood ... by Joytech Healthcare Co. , Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K200649 · Joytech Healthcare Co. , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
144d
Days
Class 2
Risk

K200649 is an FDA 510(k) clearance for the Arm-Type Fully Automatic Digital Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 3, 2020 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Joytech Healthcare Co. , Ltd. devices

Submission Details

510(k) Number K200649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2020
Decision Date August 03, 2020
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K200649.
V20, V20a, AVSM3 SNF
K200434 · Mediana Co., Ltd. · Oct 2020
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
K201467 · Bioland Technology, Ltd. · Sep 2020
Electronic Blood Pressure Monitor
K200939 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Aug 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200738 · Microlife Intellectual Property GmbH · Jul 2020
Arm Blood Pressure Monitor
K193456 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Jul 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · Dongguan E-Test Technology Co., Ltd. · Jul 2020