Cleared Traditional

K905159 - FLO-RESTER VESSEL SIZER

K905159 is an FDA 510(k) clearance for FLO-RESTER VESSEL SIZER, manufactured by Bio-Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DWP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K905159 · Bio-Vascular, Inc. · Cardiovascular device
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Feb 1991
Decision
83d
Days
Class 2
Risk

K905159 is an FDA 510(k) clearance for the FLO-RESTER(R) VESSEL SIZER. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 7, 1991 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - 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 - K905159

510(k) Number K905159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1990
Decision Date February 07, 1991
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWP Device Classification - Class 2, Special Controls

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 - DWP Dilator, Vessel, Surgical

All 11
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K905159.
Geomed Vascular Dilators
K183438 · Geomed Medizin-Technik GmbH & Co. · Sep 2019
LAPAROSCOPIC VESSEL ARTICULATOR
K911475 · United States Endoscopy Group, Inc. · Jul 1991
ROBICSEK PROBE/RETRACTOR
K910682 · Bio-Vascular, Inc. · May 1991
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · American Edwards Laboratories · Oct 1982