Cleared Traditional

K925809 - COMPRESSAR UNIVERSAL (TM) SYSTEM

K925809 is the FDA 510(k) clearance for COMPRESSAR UNIVERSAL (TM) SYSTEM by Instromedix, Inc.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K925809 · Instromedix, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
97d
Days
Class 2
Risk

K925809 is an FDA 510(k) clearance for the COMPRESSAR UNIVERSAL (TM) SYSTEM. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Instromedix, Inc. (Hillsboro, US). The FDA issued a Cleared decision on February 22, 1993 after a review of 97 days - within the typical 510(k) review window.

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 Instromedix, Inc. devices

Submission Details

510(k) Number K925809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1992
Decision Date February 22, 1993
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
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 62
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K925809.
AMR-ACV CLAMPS
K962668 · Applied Medical Resources · Nov 1996
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
ATRAUMAX SURGICAL CLAMP
K950492 · Applied Medical Resources · May 1995
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988