Cleared Traditional

K250242 - Compression Therapy Device (LGT-2202DVT) (FDA 510(k) Clearance)

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

K250242 · Guangzhou Longest Medical Technology Co., Ltd. · Cardiovascular device
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Apr 2026
Decision
452d
Days
Class 2
Risk

K250242 is an FDA 510(k) clearance for the Compression Therapy Device (LGT-2202DVT). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Guangzhou Longest Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 24, 2026 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Guangzhou Longest Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K250242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2025
Decision Date April 24, 2026
Days to Decision 452 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
327d slower than avg
Panel avg: 125d · This submission: 452d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Guangzhou Keada Biological Tech Co., Ltd.
Jett Lee

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 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K250242.
NanoPress 760A-BT (760A-BT)
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K250974 · Bio Compression Systems, Inc. · Dec 2025
Sequential Compression System (SCD600)
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · Wellell, Inc. · Oct 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446 · Manamed, LLC · Sep 2025
PnueAira (PNCU-01)
K251086 · Biotab, LLC · Aug 2025