Cleared Traditional

FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 (K982182) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982182 · Radi Medical Systems AB · Cardiovascular device
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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

Submission Details

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
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.

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 35
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K982182.
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988