Cleared Traditional

K200568 - B&J MHP800 Deep Vein Thrombosis (DVT) P...

K200568 is an FDA 510(k) clearance for B&J MHP800 Deep Vein Thrombosis (DVT) P..., manufactured by B&J Manufacturing , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K200568 · B&J Manufacturing , Ltd. · Cardiovascular device
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Jul 2020
Decision
128d
Days
Class 2
Risk

K200568 is an FDA 510(k) clearance for the B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by B&J Manufacturing , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 10, 2020 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 B&J Manufacturing , Ltd. devices

FDA 510(k) Submission Details - K200568

510(k) Number K200568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2020
Decision Date July 10, 2020
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Fu Ailing

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K200568.
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