Cleared Traditional

K915280 - FEMOSTOP

K915280 is an FDA 510(k) clearance for FEMOSTOP, manufactured by Radi Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K915280 · Radi Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
149d
Days
Class 2
Risk

K915280 is an FDA 510(k) clearance for the FEMOSTOP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on April 22, 1992 after a review of 149 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 Radi Medical Systems AB devices

FDA 510(k) Submission Details - K915280

510(k) Number K915280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date April 22, 1992
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K915280.
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992
OCCLUSION BALLON CATHETER MODIFICAION
K921399 · Interventional Therapeutics Corp. · Sep 1992
SILCLAMPS DEGANIA SILICONE
K920501 · Puritas Health Care, Inc. · Jun 1992
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
FLO-RESTER
K883696 · Bio-Vascular, Inc. · Nov 1988
VASCULAR CLAMP
K881158 · T. Korossurgical Instruments Corp. · Jun 1988