Cleared Traditional

K232270 - DVT Motion Pneumatic Compression Device

K232270 is an FDA 510(k) clearance for DVT Motion Pneumatic Compression Device, manufactured by Koge Micro Tech Co., Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K232270 · Koge Micro Tech Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
219d
Days
Class 2
Risk

K232270 is an FDA 510(k) clearance for the DVT Motion Pneumatic Compression Device. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Koge Micro Tech Co., Ltd. (New Taipei, TW). The FDA issued a Cleared decision on March 6, 2024 after a review of 219 days - an extended review cycle.

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 Koge Micro Tech Co., Ltd. devices

FDA 510(k) Submission Details - K232270

510(k) Number K232270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2023
Decision Date March 06, 2024
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
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 Peers - JOW Sleeve, Limb, Compressible

All 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K232270.
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K232300 · Elastimed , Ltd. · Dec 2023