Cleared Traditional

K842481 - AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE

K842481 is the FDA 510(k) clearance for AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code LYK) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K842481 · American Edwards Laboratories · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Oct 1984

Decision

115d

Days

Class 2

Risk

K842481 is an FDA 510(k) clearance for the AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

Submission Details

510(k) Number	K842481 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 25, 1984
Decision Date	October 18, 1984
Days to Decision	115 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

10d faster than avg

Panel avg: 125d · This submission: 115d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LYK Angioscope
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 876.1500

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 - LYK Angioscope

All 19

Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K842481.

ACS ANGIOSCOPE GUIDE WIRE

K883000 · Advanced Cardiovascular Systems, Inc. · Sep 1988

ACS CORONARY ANGIOSCOPIC CATHETER

K875108 · Advanced Cardiovascular Systems, Inc. · Sep 1988

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE

K860858 · Olympus Corp. · Nov 1986

ANGIOSCOPY CATHETER

K834547 · American Edwards Laboratories · Jun 1984

ANGIOSCOPY CATHETER

K832698 · American Edwards Laboratories · Nov 1983

ANGIOSCOPE

K830084 · Trimedyne, Inc. · Jun 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842481

American Edwards Laboratories

Santa Ana, CA · US

RONALD J EHMSEN

Regulatory profile

89 submissions 88 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active