Cleared Traditional

K090286 - PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE (FDA 510(k) Clearance)

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

K090286 · Advanced Vascular Dynamics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
46d
Days
Class 2
Risk

K090286 is an FDA 510(k) clearance for the PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Advanced Vascular Dynamics (Portland, US). The FDA issued a Cleared decision on March 23, 2009 after a review of 46 days - a notably fast clearance 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: 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 Advanced Vascular Dynamics devices

Submission Details

510(k) Number K090286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2009
Decision Date March 23, 2009
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
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 201
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K090286.
Life Saving Tourniquet
K254060 · TW Medical · Apr 2026
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · Medline Industries, LP · Nov 2025
Radial Compression Device
K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Jan 2024
PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · Compression Works, Inc. · Mar 2023