Cleared Traditional

K221654 - medi pneumatic compression system (pcs)-genius (Model 652) (FDA 510(k) Clearance)

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

K221654 · Medi USA, LP · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
30d
Days
Class 2
Risk

K221654 is an FDA 510(k) clearance for the medi pneumatic compression system (pcs)-genius (Model 652). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medi USA, LP (Whitsett, US). The FDA issued a Cleared decision on July 7, 2022 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medi USA, LP devices

Submission Details

510(k) Number K221654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2022
Decision Date July 07, 2022
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 K221654.
Compression Therapy Device (LGT-2202DVT)
K250242 · Guangzhou Longest Medical Technology Co., Ltd. · Apr 2026
NanoPress 760A-BT (760A-BT)
K254267 · Mego Afek , Ltd. · Feb 2026
Bio Arterial Deluxe (IC-BAP-DX)
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