Cleared Traditional

K944259 - FEMOSTOP II

K944259 is an FDA 510(k) clearance for FEMOSTOP II, 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 322-day FDA review.

K944259 · Radi Medical Systems AB · Cardiovascular device
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Jul 1995
Decision
322d
Days
Class 2
Risk

K944259 is an FDA 510(k) clearance for the FEMOSTOP II. 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 July 20, 1995 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K944259

510(k) Number K944259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date July 20, 1995
Days to Decision 322 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 125d · This submission: 322d
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 K944259.
HEARTPORT ENDOAORTIC CLAMP
K955132 · Heartport, Inc. · Jun 1996
FEMOSTOP, FEMOSTOP PUMP
K954669 · Radi Medical Systems AB · Oct 1995
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
ATRAUMAX SURGICAL CLAMP
K950492 · Applied Medical Resources · May 1995
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
K942812 · Bio-Vascular, Inc. · Aug 1994
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · Instromedix, Inc. · Feb 1993