Cleared Traditional

K982182 - FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0

K982182 is an FDA 510(k) clearance for FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, 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 88-day FDA review.

K982182 · Radi Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
88d
Days
Class 2
Risk

K982182 is an FDA 510(k) clearance for the FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARC.... 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 September 18, 1998 after a review of 88 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 - K982182

510(k) Number K982182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date September 18, 1998
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K982182.
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CAOW HEMOSTASIS SYSTEM
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FLO-THRU
K981624 · Bio-Vascular, Inc. · Aug 1998
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · Cardio Medical Solutions, Inc. · Jul 1998