Cleared Traditional

K851825 - SCANLAN TUNNELER

K851825 is the FDA 510(k) clearance for SCANLAN TUNNELER by Scanlan Intl., Inc.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K851825 · Scanlan Intl., Inc. · Cardiovascular device
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Jul 1985
Decision
77d
Days
Class 1
Risk

K851825 is an FDA 510(k) clearance for the SCANLAN TUNNELER, SHEATH & TIP. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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 Scanlan Intl., Inc. devices

Submission Details

510(k) Number K851825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date July 12, 1985
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 34
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K851825.
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TELEFLEX MEDICAL INTRODUCER NEEDLE
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GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
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K840305 · Imm Enterprises , Ltd. · Apr 1984