Cleared Traditional

K980898 - FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER

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 180
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K980898.
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KOALA VASCULAR CLAMPS AND INSERTS
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SURGICAL VASCULAR CLAMP
K973080 · Walter Lorenz Surgical, Inc. · Feb 1998
EZ HOLD 1 LBS., EZ HOLD 2 LBS
K973132 · Tz Medical, Inc. · Jan 1998
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
K964663 · Rmds, Inc. · Dec 1997