Cleared Traditional

K942812 - FLO-RESTER DISPOSABLE VESSEL OCCLUDER

K942812 is an FDA 510(k) clearance for FLO-RESTER DISPOSABLE VESSEL OCCLUDER, manufactured by Bio-Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K942812 · Bio-Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
48d
Days
Class 2
Risk

K942812 is an FDA 510(k) clearance for the FLO-RESTER DISPOSABLE VESSEL OCCLUDER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 48 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 Bio-Vascular, Inc. devices

FDA 510(k) Submission Details - K942812

510(k) Number K942812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1994
Decision Date August 01, 1994
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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 K942812.
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
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · Instromedix, Inc. · Feb 1993
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992
OCCLUSION BALLON CATHETER MODIFICAION
K921399 · Interventional Therapeutics Corp. · Sep 1992