Cleared Traditional

K250974 - Bio Arterial Deluxe (IC-BAP-DX) (FDA 510(k) Clearance)

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

K250974 · Bio Compression Systems, Inc. · Cardiovascular device
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Dec 2025
Decision
256d
Days
Class 2
Risk

K250974 is an FDA 510(k) clearance for the Bio Arterial Deluxe (IC-BAP-DX). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on December 12, 2025 after a review of 256 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 Bio Compression Systems, Inc. devices

Submission Details

510(k) Number K250974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2025
Decision Date December 12, 2025
Days to Decision 256 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
131d slower than avg
Panel avg: 125d · This submission: 256d
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 Peers - JOW Sleeve, Limb, Compressible

All 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K250974.
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
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