Cleared Traditional

K954669 - FEMOSTOP

K954669 is an FDA 510(k) clearance for FEMOSTOP, 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 17-day FDA review.

K954669 · Radi Medical Systems AB · Cardiovascular device
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Oct 1995
Decision
17d
Days
Class 2
Risk

K954669 is an FDA 510(k) clearance for the FEMOSTOP, FEMOSTOP PUMP. 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 October 27, 1995 after a review of 17 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 - K954669

510(k) Number K954669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date October 27, 1995
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K954669.
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
K962858 · Heartport, Inc. · Sep 1996
HEARTPORT ENDOAORTIC CLAMP
K962510 · Heartport, Inc. · Sep 1996
HEARTPORT ENDOAORTIC CLAMP
K955132 · Heartport, Inc. · Jun 1996
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
FEMOSTOP II
K944259 · Radi Medical Systems AB · Jul 1995
ATRAUMAX SURGICAL CLAMP
K950492 · Applied Medical Resources · May 1995