Cleared Traditional

K252772 - Arc Adjustable Radial Cuff Compression Device (FDA 510(k) Clearance)

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

K252772 · Tz Medical, Inc. · Cardiovascular device
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May 2026
Decision
262d
Days
Class 2
Risk

K252772 is an FDA 510(k) clearance for the Arc Adjustable Radial Cuff Compression Device. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Tz Medical, Inc. (Tualatin, US). The FDA issued a Cleared decision on May 22, 2026 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Tz Medical, Inc. devices

Submission Details

510(k) Number K252772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2025
Decision Date May 22, 2026
Days to Decision 262 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
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 202
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K252772.
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PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023
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