Cleared Traditional

K802244 - VESSEL RETRACTOR, #600732

K802244 is an FDA 510(k) clearance for VESSEL RETRACTOR, manufactured by Bentley Laboratories, Inc.. 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.

K802244 · Bentley Laboratories, Inc. · Cardiovascular device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802244 is an FDA 510(k) clearance for the VESSEL RETRACTOR, #600732. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on October 3, 1980 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.

FDA 510(k) Submission Details - K802244

510(k) Number K802244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date October 03, 1980
Days to Decision 17 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
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 204
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K802244.
OMED DISPOSABLE BULLDOG
K813499 · Omega-Med Intl., Inc. · Dec 1981
VASCULAR PAWS
K813062 · Sil-Med Corp. · Dec 1981
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K810162 · American Edwards Laboratories · Feb 1981
VASCULAR CLAMP
K801395 · Texas Medical Products, Inc. · Jun 1980
SINGLE-USE MINI-BULLDOG
K791098 · Med General · Jun 1979
VEIN CLAMPS
K772137 · A&A Ent. · Nov 1977
K802244 · VESSEL RETRACTOR, #600732
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