Cleared Traditional

K895538 - ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED...

K895538 is an FDA 510(k) clearance for ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED..., manufactured by Trimedyne, Inc.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K895538 · Trimedyne, Inc. · Cardiovascular device
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Apr 1990
Decision
225d
Days
Class 2
Risk

K895538 is an FDA 510(k) clearance for the ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Tustin, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 225 days - an extended review cycle.

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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K895538

510(k) Number K895538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1989
Decision Date April 26, 1990
Days to Decision 225 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
100d slower than avg
Panel avg: 125d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYK Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K895538.
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
K924554 · Clarus Medical Systems, Inc. · Feb 1993
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · Olympus Corp. · Jul 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991
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