Cleared Traditional

K980898 - FEMOSTOP II DISPOSABLE SET

K980898 is an FDA 510(k) clearance for FEMOSTOP II DISPOSABLE SET, 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 43-day FDA review.

K980898 · Radi Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
43d
Days
Class 2
Risk

K980898 is an FDA 510(k) clearance for the FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, F.... 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 21, 1998 after a review of 43 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 Radi Medical Systems AB devices

FDA 510(k) Submission Details - K980898

510(k) Number K980898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date April 21, 1998
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 K980898.
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
K982182 · Radi Medical Systems AB · Sep 1998
FLO-THRU
K981624 · Bio-Vascular, Inc. · Aug 1998
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998
SURGICAL VASCULAR CLAMP
K973080 · Walter Lorenz Surgical, Inc. · Feb 1998
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · Origin Medsystems, Inc. · Aug 1997
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997